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A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers (Catalyst)

Primary Purpose

Advanced Head and Neck Squamous Cell Carcinoma, Advanced Breast Cancer, Advanced Melanoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CyPep-1
Pembrolizumab 25 MG/ML [Keytruda]
Sponsored by
Cytovation AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Head and Neck Squamous Cell Carcinoma focused on measuring Cancer, Tumour, Oncology, Immunotherapy, Oncolytic, CD8, Intratumoral, Neoplasm, itRECIST

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

General Inclusion Criteria

  1. Is 18 years of age or older on the day of signing informed consent;
  2. Provides written informed consent and is able to comply with study procedures and assessments;
  3. Has measurable disease as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1;
  4. Has at least 1 non-ulcerated, measurable, and accessible lesion for intra-tumoral (IT) injection with a maximum diameter of 5 cm;
  5. Is able to provide tissue from a core or excisional biopsy at screening or has an acceptable stored tumor sample available that was collected within 90 days prior to screening;
  6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  7. Has a life expectancy >=3 months, as determined by the Investigator;
  8. Female patients of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before screening), post-menopausal, defined as spontaneous amenorrhea for at least 2 years, or with follicle-stimulating hormone in the post-menopausal range at screening;
  9. Female patients of childbearing potential (defined as <2 years after last menstruation or not surgically sterile) must have a negative serum pregnancy test at screening and agree to use a highly effective method for contraception from the time of signing the ICF until at least 120 days after the last administration of CyPep-1.
  10. If a male patient is able to father children, he must agree to use 2 acceptable methods of contraception throughout the study (eg, condom plus permicidal gel). Sperm donation is not recommended from the time of signing the ICF until at least 120 days after the last administration of CyPep-1
  11. Has adequate organ function. Specimens must be collected within 72 hours prior to the start of study treatment at Cycle 1 Visit 1.

Inclusion Criteria for Arm A

A patient who meets all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm A:

  1. Has histologically confirmed diagnosis of HNSCC;
  2. Has advanced or metastatic HNSCC incurable by standard of care therapies; and
  3. Has failed or progressed on or after prior platinum-based therapy OR has failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other therapies (if immune checkpoint inhibitor [ICI] eligible based on programmed cell death ligand 1 [PD-L1] status).

Inclusion Criteria for Arm B

A patient who meets all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm B:

  1. Has histologically confirmed diagnosis of malignant melanoma;
  2. Has advanced or metastatic melanoma incurable by standard of care therapies; and
  3. Has failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.

Inclusion Criteria for Arm C

A patient who meets all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm C:

  1. Has histologically confirmed diagnosis of TNBC;
  2. Has advanced or metastatic TNBC incurable by standard of care therapies; and
  3. Has failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other therapies (if ICI eligible based on PD-L1 status) OR has received prior systemic therapy with either an anthracycline- or taxane-containing regimen (if ICI non-eligible based on PD-L1 status).

Exclusion Criteria:

  1. Has only non-palpable cutaneous infiltrations (eg, breast cancer cutaneous carcinomatosis);
  2. Had anti-cancer therapy within 4 weeks prior to the first dose of CyPep-1 (2 weeks for palliative radiotherapy);
  3. Has participated in a clinical trial and received an investigational therapy within 30 days prior to the first dose of CyPep-1;
  4. Has received or will receive a live or live attenuated vaccine within 30 days prior to the first dose of CyPep-1; Note: Seasonal flu vaccines that do not contain live vaccine are permitted. Coronavirus Disease 2019 (COVID-19) vaccines are only permitted with documentation of the date of the vaccine if the last dose of vaccine was administered >14 days prior to the first dose of CyPep-1. The COVID-19 booster vaccine must be administered at least 14 days prior to the first dose of CyPep-1 and is not allowed during the first 3 months of the Treatment Period.
  5. Has tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to the Screening Visit; Note: Patients who have had a known SARS-CoV-2 infection >14 days prior to the Screening Visit are permitted at Investigator discretion and must present with no symptoms.
  6. Has had a major surgical procedure within 14 days prior to the first dose of CyPep-1;
  7. Is expected to require a systemic or localized antineoplastic therapy during participation in this study, excluding localized palliative radiotherapy to tumors not selected for evaluation of treatment response; Note: Use of denosumab for patients with bone metastasis is allowed.
  8. Is pregnant or breastfeeding;
  9. Has clinical evidence of a secondary malignancy actively progressing or requiring active treatment other than curative therapies for early stage (carcinoma in situ or Stage 1) carcinomas or non-melanoma skin cancer;
  10. Has had any autoimmune disease requiring immunosuppressive therapy (ie, use of disease modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose of CyPep-1; Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  11. Has a condition requiring continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive agents within 2 weeks prior to the first dose of CyPep-1. Inhaled, intranasal, or topical (only on areas outside the injected lesion[s]) and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease;
  12. Has abnormal or clinically significant coagulation parameters as determined by the Investigator (eg, prothrombin time, international normalized ratio, activated partial thromboplastin time) unless patients are on anticoagulants in which case it must be within appropriate clinical levels; Note: Patients who are on anticoagulants must be able to switch to a low molecular weight heparin or equivalent prior to Cycle 1 Day 1 and continue during the Treatment Period.
  13. Has a significant history or clinical manifestation of any allergic disorders and/or Quincke's edema (as determined by the Investigator) capable of significantly altering the absorption of drugs, of constituting a risk when taking CyPep-1 or pembrolizumab, or of interfering with the interpretation of the data;
  14. Has a known hypersensitivity to any component of CyPep-1 or pembrolizumab;
  15. Has a history of adverse reactions from treatment with ICIs, including pembrolizumab, which resulted in discontinuation of ICI or pembrolizumab or has ongoing pembrolizumab-related toxicity event(s) as per treatment-limiting toxicity definitions, except patients with ongoing endocrine disorders that are managed with replacement therapy (ie, hypothyroidism related to prior pembrolizumab treatment);
  16. Has an active infection requiring systemic therapy;
  17. Has known history or active Hepatitis B virus or Hepatitis C virus infection;
  18. Has had radiotherapy within 2 weeks prior to the first dose of CyPep-1, is in recovery from radiation toxicity, or has had radiation pneumonitis;
  19. Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease;
  20. Has had a prior allogeneic tissue/solid organ transplant, stem cell, or bone marrow transplant;
  21. Has active human immunodeficiency virus (HIV). Patient is eligible when on stable antiretroviral therapy (no change in medication or dose) for at least 4 weeks prior to screening, has confirmed virologic suppression with HIV RNA less than 50 copies/mL or the lower limit of quantification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening, and has a cluster of differentiation 4+ T cell count >350 cells/mm3 at screening. HIV-infected patients with a history of Kaposi sarcoma and/or Multicentric Castleman Disease will be excluded;
  22. Has a central nervous system (CNS) metastasis that is symptomatic, progressing, or that requires current therapy (eg, evidence of new or enlarging CNS metastasis, carcinomatous meningitis, or new neurological symptoms attributable to CNS metastasis);
  23. Has a QTcF >480 ms at screening, history of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes, with the exception of patients with controlled atrial fibrillation, pacemaker, or bundle branch block as the QTc will be prolonged due to the widened QRS; or
  24. Has a history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make participation in the study not in the best interest of the patient, in the opinion of the Investigator.

Sites / Locations

  • University of Alabama at Birmingham
  • City Of Hope
  • Henry Ford Health System
  • University of Pittsburgh Medical Center
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Houston Methodist
  • CHRU de Besançon
  • Institut Bergonie
  • CHU LilleRecruiting
  • Centre Leon BerardRecruiting
  • AP-HM - Hôpital de la TimoneRecruiting
  • Institut Paoli Calmettes
  • Hôpital Saint Louis - AP-HPRecruiting
  • Institute Gustave Roussy
  • Istituto Europeo di Oncologia
  • Azienda Ospedaliero Universitaria Senese
  • NKI/AvLRecruiting
  • Maastricht UMC
  • EMCRecruiting
  • Vall d'Hebron (VHIO)
  • Clinica Universidad de Navarra MadridRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario HM Sanchinarro
  • Clinica Universidad de Navarra PamplonaRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A: advanced or metastatic HNSCC

Arm B: advanced or metastatic melanoma

Arm C: advanced or metastatic TNBC

Arm Description

The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic HNSCC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).

The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic melanoma. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).

The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic TNBC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).

Outcomes

Primary Outcome Measures

Incidence, frequency, and seriousness of TEAEs
Incidence of DLTs
ORR based on radiological assessment according to the RECIST v1.1

Secondary Outcome Measures

PFS
OS

Full Information

First Posted
May 3, 2022
Last Updated
April 14, 2023
Sponsor
Cytovation AS
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05383170
Brief Title
A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers
Acronym
Catalyst
Official Title
A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytovation AS
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Additionally, the study will assess anti-tumor effects of CyPep-1 on injected lesions and non-injected target lesions identified at baseline, as well as local and systemic immunological effects of CyPep-1 in combination with pembrolizumab.
Detailed Description
Treatment with immune modulating agents may result in long lasting anti-tumor responses in patients with cancer. However, only a subset of patients obtains durable remission. Treatment strategies that aim at recruiting tumor antagonizing cellular components of the immune system holds great promise. CyPep-1 is a chemically synthesized peptide with oncolytic properties. It selectively targets cancer cells based on their altered molecular composition, and removes the surrounding cell membrane. This releases tumor neoantigens to the microenvironment and potentially induces an anti-tumour immune response. Preclinical studies show that CyPep-1 can synergize with anti-PD-1 antibody treatment in terms of decreased tumor volumes and prolonged Overall Survival (OS), highlighting the possible clinical utility of CyPep-1 in the combination setting with ICIs. This is an open-label, multi-center, non-randomized Phase 1b/2a study. The Phase 1b portion of the study (ie, the first 6 patients enrolled) will confirm the recommended CyPep-1 dose of 20 mg every 2 weeks (Q2W) in combination with pembrolizumab 400 mg every 6 weeks (Q6W). The patients from the Phase 1b portion will continue to the Phase 2a portion of the study (approximately 90 patients in total will be enrolled, with 30 patients per arm). The Phase 2a portion of the study will have 3 arms including patients with advanced or metastatic HNSCC, melanoma, or TNBC and will assess the efficacy, safety, and pharmacodynamics of CyPep-1 (20 mg Q2W) when administered directly into measurable tumor lesions in combination with the anti-programmed cell death protein 1 (PD-1) antibody pembrolizumab (400 mg Q6W).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Head and Neck Squamous Cell Carcinoma, Advanced Breast Cancer, Advanced Melanoma
Keywords
Cancer, Tumour, Oncology, Immunotherapy, Oncolytic, CD8, Intratumoral, Neoplasm, itRECIST

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: advanced or metastatic HNSCC
Arm Type
Experimental
Arm Description
The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic HNSCC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
Arm Title
Arm B: advanced or metastatic melanoma
Arm Type
Experimental
Arm Description
The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic melanoma. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
Arm Title
Arm C: advanced or metastatic TNBC
Arm Type
Experimental
Arm Description
The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic TNBC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
Intervention Type
Drug
Intervention Name(s)
CyPep-1
Intervention Description
Intratumoral injection
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab 25 MG/ML [Keytruda]
Other Intervention Name(s)
Keytruda
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Incidence, frequency, and seriousness of TEAEs
Time Frame
2 weeks
Title
Incidence of DLTs
Time Frame
6 weeks
Title
ORR based on radiological assessment according to the RECIST v1.1
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
PFS
Time Frame
8 weeks
Title
OS
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: General Inclusion Criteria Is 18 years of age or older on the day of signing informed consent; Provides written informed consent and is able to comply with study procedures and assessments; Has measurable disease as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1; Has at least 1 non-ulcerated, measurable, and accessible lesion for intra-tumoral (IT) injection with a maximum diameter of 5 cm; Is able to provide tissue from a core or excisional biopsy at screening or has an acceptable stored tumor sample available that was collected within 90 days prior to screening; Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Has a life expectancy >=3 months, as determined by the Investigator; Female patients of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before screening), post-menopausal, defined as spontaneous amenorrhea for at least 2 years, or with follicle-stimulating hormone in the post-menopausal range at screening; Female patients of childbearing potential (defined as <2 years after last menstruation or not surgically sterile) must have a negative serum pregnancy test at screening and agree to use a highly effective method for contraception from the time of signing the ICF until at least 120 days after the last administration of CyPep-1. If a male patient is able to father children, he must agree to use 2 acceptable methods of contraception throughout the study (eg, condom plus permicidal gel). Sperm donation is not recommended from the time of signing the ICF until at least 120 days after the last administration of CyPep-1 Has adequate organ function. Specimens must be collected within 72 hours prior to the start of study treatment at Cycle 1 Visit 1. Inclusion Criteria for Arm A Patients who meet all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm A: Have histologically confirmed diagnosis of HNSCC (including nasopharyngeal squamous cell carcinoma); Have advanced or metastatic HNSCC incurable by standard of care therapies; and Have failed or progressed on or after prior platinum-based therapy OR has failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other therapies (if immune checkpoint inhibitor [ICI] eligible based on programmed cell death ligand 1 [PD-L1] status). Inclusion Criteria for Arm B Patients who meet all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm B: Have histologically confirmed diagnosis of malignant melanoma; Do not have uveal melanoma Have advanced or metastatic melanoma incurable by standard of care therapies; Have received a combination of a BRAF inhibitor and a MEK inhibitor if diagnosed with a BRAF mutated melanoma and if clinically indicated; and Have failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. Inclusion Criteria for Arm C Patients who meet all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm C: Have histologically confirmed diagnosis of TNBC; Have advanced or metastatic TNBC incurable by standard of care therapies; Have received sacituzumab govitecan chemotherapeutic treatment if clinically indicated; and Have failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other therapies (if ICI eligible based on PD-L1 status) OR have received prior systemic therapy with either an anthracycline- or taxane-containing regimen (if ICI non-eligible based on PD-L1 status). Exclusion Criteria: Has only non-palpable cutaneous infiltrations (eg, breast cancer cutaneous carcinomatosis); Had anti-cancer therapy within 4 weeks prior to the first dose of CyPep-1 (2 weeks for palliative radiotherapy); Has participated in a clinical trial and received an investigational therapy within 30 days prior to the first dose of CyPep-1; Has received or will receive a live or live attenuated vaccine within 30 days prior to the first dose of CyPep-1; Note: Seasonal flu vaccines that do not contain live vaccine are permitted. Coronavirus Disease 2019 (COVID-19) vaccines are only permitted with documentation of the date of the vaccine if the last dose of vaccine was administered >14 days prior to the first dose of CyPep-1. The COVID-19 booster vaccine must be administered at least 14 days prior to the first dose of CyPep-1 and is not allowed during the first 3 months of the Treatment Period. Has tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to the Screening Visit; Note: Patients who have had a known SARS-CoV-2 infection >14 days prior to the Screening Visit are permitted at Investigator discretion and must present with no symptoms. Has had a major surgical procedure within 14 days prior to the first dose of CyPep-1; Is expected to require a systemic or localized antineoplastic therapy during participation in this study, excluding localized palliative radiotherapy to tumors not selected for evaluation of treatment response; Note: Use of denosumab for patients with bone metastasis is allowed. Is pregnant or breastfeeding; Has clinical evidence of a secondary malignancy actively progressing or requiring active treatment other than curative therapies for early stage (carcinoma in situ or Stage 1) carcinomas or non-melanoma skin cancer; Has had any autoimmune disease requiring immunosuppressive therapy (ie, use of disease modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose of CyPep-1; Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Has a condition requiring continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of CyPep-1. Inhaled, intranasal, or topical (only on areas outside the injected lesion[s]) and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease; Has abnormal or clinically significant coagulation parameters as determined by the Investigator (eg, prothrombin time, international normalized ratio, activated partial thromboplastin time) unless patients are on anticoagulants in which case it must be within appropriate clinical levels; Note: Patients who are on anticoagulants must be able to switch to a low molecular weight heparin or equivalent prior to Cycle 1 Day 1 and continue during the Treatment Period. Has a significant history or clinical manifestation of any allergic disorders and/or Quincke's edema (as determined by the Investigator) capable of significantly altering the absorption of drugs, of constituting a risk when taking CyPep-1 or pembrolizumab, or of interfering with the interpretation of the data; Has a known hypersensitivity to any component of CyPep-1 or pembrolizumab; Has a history of adverse reactions from treatment with ICIs, including pembrolizumab, which resulted in discontinuation of ICI or pembrolizumab or has ongoing pembrolizumab-related toxicity event(s) as per treatment-limiting toxicity definitions, except patients with ongoing endocrine disorders that are managed with replacement therapy (ie, hypothyroidism related to prior pembrolizumab treatment); Has an active infection requiring systemic therapy; Has a known history of Hepatitis B or known active Hepatitis C virus infection; Has had radiotherapy within 2 weeks prior to the first dose of CyPep-1, is in recovery from radiation toxicity, or has had radiation pneumonitis; Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; Has had a prior allogeneic tissue/solid organ transplant, stem cell, or bone marrow transplant; Has active human immunodeficiency virus (HIV). Patient is eligible when on stable antiretroviral therapy (no change in medication or dose) for at least 4 weeks prior to screening, has confirmed virologic suppression with HIV RNA less than 50 copies/mL or the lower limit of quantification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening, and has a cluster of differentiation 4+ T cell count >350 cells/mm3 at screening. HIV-infected patients with a history of Kaposi sarcoma and/or Multicentric Castleman Disease will be excluded; Have 4 or more sites involved, including the primary cancer; Note: A site is defined as an organ (eg, lung, liver, or brain) or a system (eg, lymphatic or central nervous system [CNS]). Has a central nervous system (CNS) metastasis that is symptomatic, progressing, or that requires current therapy (eg, evidence of new or enlarging CNS metastasis, carcinomatous meningitis, or new neurological symptoms attributable to CNS metastasis); Has a QTcF >480 ms at screening, history of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes, with the exception of patients with controlled atrial fibrillation, pacemaker, or bundle branch block as the QTc will be prolonged due to the widened QRS; Are an adult under legal protection, are vulnerable, or lack the capacity to give informed consent, such as: persons deprived of liberty by a judicial or administrative decision; adult persons subject to a legal protection measure (under supervision/under guardianship); or persons under a judicial protection measure; or Has a history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make participation in the study not in the best interest of the patient, in the opinion of the Investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Prestegarden, MD PhD
Phone
0047718809
Email
lars@cytovation.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar Pico, MD
Organizational Affiliation
Cytovation AS
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elkhanany, MD
Facility Name
City Of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Villaflor, MD
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali, MD
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2582
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Najjar, MD
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cowey, MD
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernicker, MD
Facility Name
CHRU de Besançon
City
Besançon Cedex
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mansi, MD
Facility Name
Institut Bergonie
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Italiano, MD
Facility Name
CHU Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mortier, MD
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayette, MD
Facility Name
AP-HM - Hôpital de la Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaudy, MD
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rochigneux, MD
Facility Name
Hôpital Saint Louis - AP-HP
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lebbe, MD
Facility Name
Institute Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Champiat, MD
Facility Name
Istituto Europeo di Oncologia
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Curigliano, MD
Facility Name
Azienda Ospedaliero Universitaria Senese
City
Siena
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maio, MD
Facility Name
NKI/AvL
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Opdam, MD
Facility Name
Maastricht UMC
City
Maastricht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aarts, MD
Facility Name
EMC
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eskens, MD
Facility Name
Vall d'Hebron (VHIO)
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Munoz Couselo, MD
Facility Name
Clinica Universidad de Navarra Madrid
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lopez Picazo, MD
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
de Velasco Oria de Rueda, MD
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
de Miguel Luken, MD
Facility Name
Clinica Universidad de Navarra Pamplona
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lopez-Picazo Gonzalez, MD
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
de la Cruz, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27924752
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PubMed Identifier
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Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D'Angelo SP, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019 Feb;51(2):202-206. doi: 10.1038/s41588-018-0312-8. Epub 2019 Jan 14.
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PubMed Identifier
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Citation
Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971.
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Snyder A, Makarov V, Merghoub T, Yuan J, Zaretsky JM, Desrichard A, Walsh LA, Postow MA, Wong P, Ho TS, Hollmann TJ, Bruggeman C, Kannan K, Li Y, Elipenahli C, Liu C, Harbison CT, Wang L, Ribas A, Wolchok JD, Chan TA. Genetic basis for clinical response to CTLA-4 blockade in melanoma. N Engl J Med. 2014 Dec 4;371(23):2189-2199. doi: 10.1056/NEJMoa1406498. Epub 2014 Nov 19. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.
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PubMed Identifier
23651186
Citation
Vesely MD, Schreiber RD. Cancer immunoediting: antigens, mechanisms, and implications to cancer immunotherapy. Ann N Y Acad Sci. 2013 May;1284(1):1-5. doi: 10.1111/nyas.12105.
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PubMed Identifier
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Citation
Zappasodi R, Merghoub T, Wolchok JD. Emerging Concepts for Immune Checkpoint Blockade-Based Combination Therapies. Cancer Cell. 2018 Apr 9;33(4):581-598. doi: 10.1016/j.ccell.2018.03.005. Erratum In: Cancer Cell. 2018 Oct 8;34(4):690.
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PubMed Identifier
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Citation
Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litiere S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2. Erratum In: Lancet Oncol. 2019 May;20(5):e242.
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A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers

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