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Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS) (ORPHEUS)

Primary Purpose

Penile Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INCMGA0012
Sponsored by
MedSIR
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Penile Cancer focused on measuring Penile Cancer, Penile squamous cell carcinoma, Locally advanced penile cancer, Metastatic penile cancer, Unresectable locally advanced penile cancer, Unresectable penile cancer, PSqCC, PSCC, Penile Cancer stage IV

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form (ICF) prior to participation in any study-related activities.
  2. Male patients ≥ 18 years of age at the time of signing ICF.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
  4. Life expectancy ≥12 weeks.
  5. Histologically-proven PSqCC.
  6. Locally advanced unresectable or metastatic stage 4 PSqCC that is not amenable to resection with curative intent (T4 or N3 or M1).
  7. Radiological evidence of locally advanced or metastatic disease.
  8. Patients must have measurable disease or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria.
  9. Patients must agree to provide a tumor tissue sample from a metastatic site or the primary tumor at the time of study entry, with the exception of patients whom tumor biopsies cannot be obtained (e.g., inaccessible tumor or subject safety concern) that may submit an archived tumor specimen only upon agreement from the Sponsor. If feasible, patients will also be given the option of providing a tumor tissue sample at disease progression from metastasis or primary tumor (if tumor biopsies cannot be obtained for inaccessible lesion or subject safety concern).
  10. Willingness and ability to provide blood samples (liquid biopsy) at the time of inclusion, after 2 cycles of study treatment (C3D1), and upon PD or study termination.
  11. Adequate organ function:

    1. Hematological: White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 75.0 x109/L, and hemoglobin > 9.0 g/dL.
    2. Hepatic: Bilirubin ≤ 1.5 times the upper limit of normal (× ULN) (< 3 x ULN in the case of Gilbert's disease); aspartate transaminase (AST), and alanine transaminase (ALT) ≤ 2.5 times × ULN (in the case of liver metastases ≤ 5 × ULN); Albumin > 2.5 mg/mL.
    3. Renal: Serum creatinine ≤ 1.5 x ULN; alternately measured or calculated creatinine clearance ≥30 mL/min with creatinine levels >1.5 × institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance).
    4. Coagulation: Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN and International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  12. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  13. Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 180 days after the last dose of study treatment.
  14. Patients that have received prior chemotherapy regimens or radiotherapy for locally recurrent and/or metastatic disease are not excluded but patients naïve of systemic treatment can also be included.
  15. For pretreated patients, last dose of chemotherapy administered ≥ 28 days from study entry.

Exclusion criteria

  1. Locally PSqCC candidate for curative treatment.
  2. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  3. Known hypersensitivity to any of the excipients of INCMGA00012.
  4. Receipt of anticancer therapy or participation in another interventional clinical study within 28 days before the first administration of study drug; 6 weeks for mitomycin C.
  5. Radiotherapy within 14 days of first dose of study treatment with the following caveat: 28 days for pelvic radiotherapy.
  6. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with Sponsor's medical monitor.
  7. Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 4 weeks of start of study drug, or patients who have not recovered from the side effects of any major surgery, or patients who may require major surgery during the study.
  8. Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated (e.g., radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
  9. Cardiovascular: patients that have any of the following within 6 months of randomization: severe/unstable angina, myocardial infarction, symptomatic pericarditis, symptomatic congestive heart failure (New York Heart Association functional classification III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism, coronary/peripheral artery bypass graft, ongoing cardiac dysrhythmias of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0 grade ≥2, including, ventricular arrhythmias -except for benign premature ventricular contractions-, supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication, any conduction abnormality requiring a pacemaker or any cardiac arrhythmia not controlled with medication.
  10. Metabolic: Uncontrolled hyper/hypothyroidism or diabetes mellitus type 1 (T1DM). Patients with hypothyroidism stable on hormone replacement will not be excluded from the trial. Patients with controlled T1DM on a stable insulin regimen may be eligible for this study.
  11. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or immunosuppressive therapy within seven days prior to study treatment initiation.
  12. Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).

    Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic steroid replacement therapy (≤ 10 mg prednisone daily) for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

  13. Prior allogenic stem cell or solid organ transplantation.
  14. Has received a live vaccine within 28 days of the planned start of study drug. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live-attenuated vaccines and are not allowed.
  15. Active/history of pneumonitis requiring treatment with steroids or active/history of interstitial lung disease.
  16. Active uncontrolled infection at the time of screening.
  17. Latent tuberculosis determined by a positive TST followed by confirmation by pulmonologists.
  18. Participants who are known to be human immunodeficiency virus (HIV)-positive, unless all of the following criteria are met:

    1. CD4-positive count ≥ 300/μL;
    2. Undetectable viral load;
    3. Receiving highly active antiretroviral therapy.
  19. Active hepatitis A virus (HAV) (positivity for HAV IgM antibody), hepatitis B virus (HBV) (patients with negative hepatitis B surface antigen [HBsAg] test and a positive antibody to HBsAg [anti-HBsAg] test at screening are eligible) or hepatitis C virus (HCV) (patients with a positive antibody to hepatitis C [anti-HCV] are eligible only if polymerase chain reaction [PCR] is negative for virus hepatitis C ribonucleic acid [RNA]).
  20. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for >1 year, after treatment with curative intent.
  21. Patients have any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment contraindicate patient participation in the clinical study.

Sites / Locations

  • IRCCS Ospedale San Raffaele
  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
  • AUSL Reggio Emilia
  • Hospital de la Santa Creu i Sant Pau
  • ICO-Hospitalet
  • Hospital 12 de octubre
  • Hospital Clínico San Carlos
  • Hospital Virgen de la Arrixaca
  • Hospital Universitari Son Espases
  • Hospital Insular de Gran Canaria
  • Hospital Virgen del Rocío
  • Instituto Valenciano de Oncología
  • Hospital Miguel Servet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional arm

Arm Description

Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
The primary efficacy endpoint for the study is the ORR. The ORR is defined as the number of patients with CR and PR divided by the number of patients in the analysis set. Tumor response will be defined as best response based on local investigator's assessment according to RECIST criteria v.1.1.

Secondary Outcome Measures

Efficacy determined by Clinical Benefit Rate (CBR)
CBR is defined as the number of patients with CR, partial response (PR) or stable disease (SD) (for at least 12 weeks) divided by the number of patients in the analysis set.
Efficacy determined by Progression-free survival (PFS)
PFS is defined as the time from the date of the first dose of study treatment until the first documented PD based on RECIST v1.1. or death due to any cause, whichever occurs first based on local investigator's assessment according to RECIST criteria v1.1.
Efficacy determined by 6-months PFS
6-months PFS rate is defined as the proportion of patients who are alive and progression-free at 6 months from the date of first dose of study treatment based on iRECIST criteria.
Efficacy determined by Duration of Response (DoR)
DoR is defined as the time from first documented CR or PR until disease progression or death from any cause, based on local investigator's assessment according to RECIST criteria v1.1.
Efficacy determined by Overall survival (OS)
OS is defined as the time from the date of first dose of study treatment until death by any cause or the last date the patient was known to be alive.
Efficacy determined by maximum tumor shrinkage
Maximum tumor shrinkage is defined as the percentage of tumor shrinkage from baseline (obtained from the sum of largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria v1.1.
Safety adverse events (AEs)
Number of patients with treatment-related AEs (Grade 3 and 4 AEs and serious adverse events [SAEs]) by using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.

Full Information

First Posted
January 9, 2020
Last Updated
January 18, 2023
Sponsor
MedSIR
Collaborators
Incyte Biosciences International Sàrl
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1. Study Identification

Unique Protocol Identification Number
NCT04231981
Brief Title
Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)
Acronym
ORPHEUS
Official Title
A Multicenter, Open-Label, Single-Arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedSIR
Collaborators
Incyte Biosciences International Sàrl

4. Oversight

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

5. Study Description

Brief Summary
This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate the efficacy and safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma
Detailed Description
Men age ≥ 18 years with locally advanced unresectable or metastatic PSqCC stage 4 (i.e. T4 or N3 or M1) that are presenting with radiologic progression of disease (PD) following or not standard treatment with chemotherapy. After signing the ICF and confirmed eligibility, patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle, once every four weeks for up to 2 years. Patients will receive treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected every 3 months (± 14 days) from the last dose of investigational product until the end of study (EoS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penile Cancer
Keywords
Penile Cancer, Penile squamous cell carcinoma, Locally advanced penile cancer, Metastatic penile cancer, Unresectable locally advanced penile cancer, Unresectable penile cancer, PSqCC, PSCC, Penile Cancer stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Multicenter, open-label, single-arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle.
Intervention Type
Drug
Intervention Name(s)
INCMGA0012
Intervention Description
INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The primary efficacy endpoint for the study is the ORR. The ORR is defined as the number of patients with CR and PR divided by the number of patients in the analysis set. Tumor response will be defined as best response based on local investigator's assessment according to RECIST criteria v.1.1.
Time Frame
Baseline up to 24 months
Secondary Outcome Measure Information:
Title
Efficacy determined by Clinical Benefit Rate (CBR)
Description
CBR is defined as the number of patients with CR, partial response (PR) or stable disease (SD) (for at least 12 weeks) divided by the number of patients in the analysis set.
Time Frame
Baseline up to 24 months
Title
Efficacy determined by Progression-free survival (PFS)
Description
PFS is defined as the time from the date of the first dose of study treatment until the first documented PD based on RECIST v1.1. or death due to any cause, whichever occurs first based on local investigator's assessment according to RECIST criteria v1.1.
Time Frame
Baseline up to 24 months
Title
Efficacy determined by 6-months PFS
Description
6-months PFS rate is defined as the proportion of patients who are alive and progression-free at 6 months from the date of first dose of study treatment based on iRECIST criteria.
Time Frame
Baseline up to 6 months
Title
Efficacy determined by Duration of Response (DoR)
Description
DoR is defined as the time from first documented CR or PR until disease progression or death from any cause, based on local investigator's assessment according to RECIST criteria v1.1.
Time Frame
Baseline up to 24 months
Title
Efficacy determined by Overall survival (OS)
Description
OS is defined as the time from the date of first dose of study treatment until death by any cause or the last date the patient was known to be alive.
Time Frame
Baseline up to 24 months
Title
Efficacy determined by maximum tumor shrinkage
Description
Maximum tumor shrinkage is defined as the percentage of tumor shrinkage from baseline (obtained from the sum of largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria v1.1.
Time Frame
Baseline up to 24 months
Title
Safety adverse events (AEs)
Description
Number of patients with treatment-related AEs (Grade 3 and 4 AEs and serious adverse events [SAEs]) by using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.
Time Frame
Baseline up to 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form (ICF) prior to participation in any study-related activities. Male patients ≥ 18 years of age at the time of signing ICF. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. Life expectancy ≥12 weeks. Histologically-proven PSqCC. Locally advanced unresectable or metastatic stage 4 PSqCC that is not amenable to resection with curative intent (T4 or N3 or M1). Radiological evidence of locally advanced or metastatic disease. Patients must have measurable disease or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria. Patients must agree to provide a tumor tissue sample from a metastatic site or the primary tumor at the time of study entry, with the exception of patients whom tumor biopsies cannot be obtained (e.g., inaccessible tumor or subject safety concern) that may submit an archived tumor specimen only upon agreement from the Sponsor. If feasible, patients will also be given the option of providing a tumor tissue sample at disease progression from metastasis or primary tumor (if tumor biopsies cannot be obtained for inaccessible lesion or subject safety concern). Willingness and ability to provide blood samples (liquid biopsy) at the time of inclusion, after 2 cycles of study treatment (C3D1), and upon PD or study termination. Adequate organ function: Hematological: White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 75.0 x109/L, and hemoglobin > 9.0 g/dL. Hepatic: Bilirubin ≤ 1.5 times the upper limit of normal (× ULN) (< 3 x ULN in the case of Gilbert's disease); aspartate transaminase (AST), and alanine transaminase (ALT) ≤ 2.5 times × ULN (in the case of liver metastases ≤ 5 × ULN); Albumin > 2.5 mg/mL. Renal: Serum creatinine ≤ 1.5 x ULN; alternately measured or calculated creatinine clearance ≥30 mL/min with creatinine levels >1.5 × institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance). Coagulation: Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN and International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 180 days after the last dose of study treatment. Patients that have received prior chemotherapy regimens or radiotherapy for locally recurrent and/or metastatic disease are not excluded but patients naïve of systemic treatment can also be included. For pretreated patients, last dose of chemotherapy administered ≥ 28 days from study entry. Exclusion criteria Locally PSqCC candidate for curative treatment. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Known hypersensitivity to any of the excipients of INCMGA00012. Receipt of anticancer therapy or participation in another interventional clinical study within 28 days before the first administration of study drug; 6 weeks for mitomycin C. Radiotherapy within 14 days of first dose of study treatment with the following caveat: 28 days for pelvic radiotherapy. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with Sponsor's medical monitor. Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 4 weeks of start of study drug, or patients who have not recovered from the side effects of any major surgery, or patients who may require major surgery during the study. Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated (e.g., radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization. Cardiovascular: patients that have any of the following within 6 months of randomization: severe/unstable angina, myocardial infarction, symptomatic pericarditis, symptomatic congestive heart failure (New York Heart Association functional classification III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism, coronary/peripheral artery bypass graft, ongoing cardiac dysrhythmias of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0 grade ≥2, including, ventricular arrhythmias -except for benign premature ventricular contractions-, supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication, any conduction abnormality requiring a pacemaker or any cardiac arrhythmia not controlled with medication. Metabolic: Uncontrolled hyper/hypothyroidism or diabetes mellitus type 1 (T1DM). Patients with hypothyroidism stable on hormone replacement will not be excluded from the trial. Patients with controlled T1DM on a stable insulin regimen may be eligible for this study. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or immunosuppressive therapy within seven days prior to study treatment initiation. Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic steroid replacement therapy (≤ 10 mg prednisone daily) for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Prior allogenic stem cell or solid organ transplantation. Has received a live vaccine within 28 days of the planned start of study drug. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live-attenuated vaccines and are not allowed. Active/history of pneumonitis requiring treatment with steroids or active/history of interstitial lung disease. Active uncontrolled infection at the time of screening. Latent tuberculosis determined by a positive TST followed by confirmation by pulmonologists. Participants who are known to be human immunodeficiency virus (HIV)-positive, unless all of the following criteria are met: CD4-positive count ≥ 300/μL; Undetectable viral load; Receiving highly active antiretroviral therapy. Active hepatitis A virus (HAV) (positivity for HAV IgM antibody), hepatitis B virus (HBV) (patients with negative hepatitis B surface antigen [HBsAg] test and a positive antibody to HBsAg [anti-HBsAg] test at screening are eligible) or hepatitis C virus (HCV) (patients with a positive antibody to hepatitis C [anti-HCV] are eligible only if polymerase chain reaction [PCR] is negative for virus hepatitis C ribonucleic acid [RNA]). Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for >1 year, after treatment with curative intent. Patients have any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment contraindicate patient participation in the clinical study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier García del Muro
Organizational Affiliation
ICO- Hospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
City
Milan
Country
Italy
Facility Name
AUSL Reggio Emilia
City
Reggio Emilia
Country
Italy
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
ICO-Hospitalet
City
Hospitalet de Llobregat
Country
Spain
Facility Name
Hospital 12 de octubre
City
Madrid
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Universitari Son Espases
City
Palma De Mallorca
Country
Spain
Facility Name
Hospital Insular de Gran Canaria
City
Palmas de Gran Canaria
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Instituto Valenciano de Oncología
City
Valencia
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

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Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)

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