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Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin

Primary Purpose

Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hypopharyngeal Squamous Cell Carcinoma, Advanced Laryngeal Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intensity-Modulated Radiation Therapy
Peposertib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Pathologically (histologically) proven diagnosis of HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx prior to registration;

    • Patients with oropharynx cancer need p16 determination by immunohistochemistry (where positive is defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells), Note: Institutions must screen patients using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the United States (U.S.) CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable. The p16 results must be reported on the pathology report being submitted;
    • Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer must be stages T1-2N2-3 or T3N1-3 or T4N0-3 (American Joint Committee on Cancer [AJCC] version 8);
    • p16-positive oropharynx cancer patients, stages T4N0-3 or T1-3N2-3 (AJCC version 8);
    • The patient has measurable disease as defined by the presence of at least one measurable lesion per RECIST 1.1;
    • Please note: A histological or pathological specimen from cervical lymph nodes with well-defined primary site documented clinically or radiologically is acceptable
  • Clinical stage noted above should be based upon following diagnostic workup:

    • History/physical examination within 30 days prior to registration;
    • Examination by radiation oncologist or medical oncologist or otolaryngology (ENT) or head & neck surgeon 30 days prior to registration, including fiber optic exam with laryngopharyngoscopy;
    • Diagnostic quality computed tomography (CT) or magnetic resonance imaging (MRI) of neck, with contrast, within 30 days prior to registration. Fludeoxyglucose F-18 (18F-FDG) whole body positron emission tomography (PET)-CT scan within 42 days of registration is strongly recommended but does not replace the CT or MRI study. Note: If CT component of the PET/CT is of diagnostic quality then PET/CT can be used for eligibility, however the PET/CT scan must be done within 30 days prior to registration
    • Diagnostic quality, cross sectional imaging of the thorax within 42 days prior to registration; 18-F-FDG-PET/CT or conventional CT are acceptable
  • Age >= 18 years
  • Patients must have a contraindication to cisplatin as defined in the following bullet points. Sites must complete the online tool at comogram.org prior to registration to determine if the patient is eligible. The scores must be recorded on a case report form (CRF). (Refer to data submission table on the NRG-HN008 protocol page on the NRG website);

    • Age >= 70 with moderate to severe comorbidity, defined as having one or more of the following conditions within 30 days prior to registration;

      • Modified Charlson Comorbidity Index >= 1
      • Adult Comorbidity Evaluation (ACE)-27 Index >= 1
      • Omega score < 0.80
      • G-8 score =< 14
      • Cancer and Aging Research Group (CARG) Toxicity Score >= 30%
      • Cumulative Illness Rating Scale for Geriatrics (CIRS-G) Score >= 4 OR
    • Age < 70 with severe comorbidity, defined as having two or more of the following conditions within 30 days prior to registration;

      • Modified Charlson Comorbidity Index >= 1
      • ACE-27 Index >= 1
      • Omega score < 0.80
      • G-8 score =< 14
      • CARG Toxicity Score >= 30%
      • CIRS-G Score >= 4 OR
    • Age >= 18 with an absolute or relative contraindication to cisplatin, defined as one or more of the following criterion within 30 days prior to registration:

      • Pre-existing peripheral neuropathy grade >= 1;
      • Creatinine clearance (CrCl) must be > 30 and < 60 mL/min

        • For this calculation, use the Cockcroft-Gault formula
      • History of hearing loss, defined as either:

        • Existing need of a hearing aid OR
        • >= 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated
  • Zubrod Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 30 days prior to registration
  • Whole blood cell (WBC) >= 2000 cells/mm^3 (within 30 days prior to registration)
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to registration)
  • Platelets >= 100,000 cells/mm^3 (within 30 days prior to registration)
  • Hemoglobin >= 9.0 g/dL (within 30 days prior to registration); Note: The use of transfusion is acceptable
  • Creatinine clearance (CrCl) > 30 mL/min (within 30 days prior to registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (except patients with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL) (within 30 days prior to registration)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (within 30 days prior to registration)
  • For women of child bearing potential (e.g. uterus present and menstruating), a negative serum pregnancy test within 14 days prior to registration. Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
  • The patient must provide study-specific informed consent prior to study entry
  • Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4 T cell count >= 200 are eligible for this trial. Testing is not required for entry into protocol
  • Patients with a history of hepatitis B or C infection are eligible if they have an undetectable viral load
  • Willing to use highly effective contraceptives for males and females of childbearing potential during therapy and for 12 weeks after the last dose of M3814 (peposertib); this inclusion is necessary because the treatment in this study may be significantly teratogenic
  • Patients must be able to swallow whole tablets

Exclusion Criteria:

  • Definitive clinical or radiologic evidence of distant (beyond cervical lymph node and neck tissue) metastatic disease
  • Carcinoma of the neck of unknown primary site origin
  • Patients with oral cavity cancer are excluded from participation if the patient is medically operable and the resection of the primary tumor is considered technically feasible by an oral or head and neck cancer surgical subspecialist
  • Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease

    • Note: Patients with RECIST, version (v.) 1.1 evaluable remaining cancer either in the neck or primary site remain eligible
  • Prior invasive malignancy (except non-melanomatous skin cancer carcinoma, in situ of the breast, oral cavity, or cervix, low or very low-risk prostate cancer) unless disease free for a minimum of 3 years
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if not within =< 3 years
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity defined as follows:

    • History of bone marrow transplant and organ transplant, including allogenic stem cell transplantation;
    • Unstable angina requiring hospitalization in the last 6 months;
    • New York Heart Association Functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.);
    • Myocardial infarction within the last 6 months;
    • Persistent grade 3-4 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) electrolyte abnormalities that cannot be reversed despite as indicated by repeat testing;
    • Ongoing active infection that is associated with symptoms and/or requires antibiotic therapy at the time of registration (excluding asymptomatic bacteriuria, genital herpes, oral herpes, thrush, bacterial vaginosis, vaginal candidiasis, topical antifungals)
  • Pregnancy and nursing females, if applicable
  • Concomitant use of proton pump inhibitors (or unable to stop 5 days prior to treatment)
  • Receipt of live vaccinations within 28 days prior to registration
  • Patients unable to discontinue medications or substances that are:

    • Strong inhibitors, inducers or sensitive substrates of CYP3A4/5, CYP2C19, or CYP2C9 prior to study treatment;
    • Substrates of CYP1A2, CYP2B6, or CYP3A4/5 with a narrow therapeutic prior to study treatment;

      • Note: Opioids are allowed, with the exception of methadone
  • Fridericia's correction formula (QTcF) > 450 ms for males and > 470 ms for females

Sites / Locations

  • Banner MD Anderson Cancer CenterRecruiting
  • Mayo Clinic Hospital in ArizonaRecruiting
  • Banner University Medical Center - TucsonRecruiting
  • University of Arizona Cancer Center-North CampusRecruiting
  • UC San Diego Moores Cancer CenterRecruiting
  • Stanford Cancer Institute Palo AltoRecruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
  • Moffitt Cancer CenterRecruiting
  • Emory University Hospital MidtownRecruiting
  • Emory University Hospital/Winship Cancer Institute
  • The James Graham Brown Cancer Center at University of LouisvilleRecruiting
  • Highland HospitalRecruiting
  • University of RochesterRecruiting
  • Ohio State University Comprehensive Cancer CenterRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • Providence Portland Medical CenterRecruiting
  • Medical University of South Carolina
  • Sanford Cancer Center Oncology ClinicRecruiting
  • Sanford USD Medical Center - Sioux FallsRecruiting
  • M D Anderson Cancer CenterRecruiting
  • Inova Schar Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (peposertib, IMRT)

Arm Description

Beginning 60-90 minutes before each radiation treatment, patients receive peposertib PO QD and undergo IMRT daily Monday-Friday for 7 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Dose-limiting toxicity

Secondary Outcome Measures

Incidence of acute toxicity
Will be as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0
Incidence of late toxicity
Will be as measured by CTCAE v5.0.
Clinical response rate
Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1.
Progression-free survival (PFS) rates
Will be estimated using the Kaplan-Meier (K-M) method (Kaplan and Meier 1958). Point estimates of the PFS at 6 months and 1 year post-IMRT along with their 95% confidence intervals after using a log-log transformation will be calculated using the K-M curves.
Overall survival (OS) rates
Will be estimated using the Kaplan-Meier (K-M) method (Kaplan and Meier 1958). Point estimates of the OS at 6 months and 1 year post-IMRT along with their 95% confidence intervals after using a log-log transformation will be calculated using the K-M curves.

Full Information

First Posted
August 29, 2020
Last Updated
September 26, 2023
Sponsor
National Cancer Institute (NCI)
Collaborators
NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT04533750
Brief Title
Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
Official Title
Phase I Trial With Expansion Cohort of DNA-PK Inhibition and IMRT in Cisplatin-Ineligible Patients With Stage 3-4 Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
NRG Oncology

4. Oversight

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

5. Study Description

Brief Summary
This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.
Detailed Description
PRIMARY OBJECTIVE: I. To determine the recommended phase 2 dose (RP2D) of M3814 (peposertib) when given in combination with intensity-modulated radiation therapy (IMRT). SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of the combination of M3814 (peposertib) with radiotherapy. II. To estimate the rates of grade 3 or greater acute toxicities of the regimen. III. To estimate late toxicities of the regimen. IV. To evaluate the clinical response rate, based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at 3 months post completion of radiotherapy. V. To estimate 6 and 12-month progression-free survival (PFS) in the dose expansion cohort (DEC). VI. To estimate 6 and 12-month overall survival (OS) in the DEC. EXPLORATORY OBJECTIVE: I. To estimate the pharmacokinetic (PK) parameter of M3814 (peposertib) using population PK approaches. OUTLINE: This is a dose-escalation study of peposertib. Beginning 60-90 minutes before each radiation treatment, patients receive peposertib orally (PO) once daily (QD) and undergo IMRT daily Monday-Friday for 7 weeks in the absence of disease progression or unacceptable toxicity. After completion of treatment, patients are followed up every 3 months for 2 years.

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 Hypopharyngeal Squamous Cell Carcinoma, Advanced Laryngeal Squamous Cell Carcinoma, Advanced Oral Cavity Squamous Cell Carcinoma, Advanced Oropharyngeal Squamous Cell Carcinoma, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (peposertib, IMRT)
Arm Type
Experimental
Arm Description
Beginning 60-90 minutes before each radiation treatment, patients receive peposertib PO QD and undergo IMRT daily Monday-Friday for 7 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Radiation
Intervention Name(s)
Intensity-Modulated Radiation Therapy
Other Intervention Name(s)
IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Intervention Description
Undergo IMRT
Intervention Type
Drug
Intervention Name(s)
Peposertib
Other Intervention Name(s)
3-Pyridazinemethanol, alpha-(2-Chloro-4-fluoro-5-(7-(4-morpholinyl)-4-quinazolinyl)phenyl)-6-methoxy-, (alphaS)-, M 3814, M-3814, M3814, MSC 2490484A, MSC-2490484A, MSC2490484A, Nedisertib
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Dose-limiting toxicity
Time Frame
Up to 28 days after the end of intensity-modulated radiation therapy (IMRT)
Secondary Outcome Measure Information:
Title
Incidence of acute toxicity
Description
Will be as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0
Time Frame
Up to 3 months from IMRT completion
Title
Incidence of late toxicity
Description
Will be as measured by CTCAE v5.0.
Time Frame
More than 3 months from IMRT completion for up to 2 years
Title
Clinical response rate
Description
Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1.
Time Frame
At 3 months post completion of IMRT
Title
Progression-free survival (PFS) rates
Description
Will be estimated using the Kaplan-Meier (K-M) method (Kaplan and Meier 1958). Point estimates of the PFS at 6 months and 1 year post-IMRT along with their 95% confidence intervals after using a log-log transformation will be calculated using the K-M curves.
Time Frame
At 6 months and 1 year
Title
Overall survival (OS) rates
Description
Will be estimated using the Kaplan-Meier (K-M) method (Kaplan and Meier 1958). Point estimates of the OS at 6 months and 1 year post-IMRT along with their 95% confidence intervals after using a log-log transformation will be calculated using the K-M curves.
Time Frame
At 6 months and 1 year
Other Pre-specified Outcome Measures:
Title
Pharmacokinetic (PK) parameter of M3814 (peposertib)
Description
Plasma PK values will be estimated in the context of the Merck popPK model at the end of the trial and reported as such. PK-outcome relationships may be assessed in an exploratory fashion.
Time Frame
Within 30 minutes before administration, 2 hours and 4 hours after administration on day 1 of weeks 1 and 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically (histologically) proven diagnosis of HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx prior to registration; Patients with oropharynx cancer need p16 determination by immunohistochemistry (where positive is defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells), Note: Institutions must screen patients using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the United States (U.S.) CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable. The p16 results must be reported on the pathology report being submitted; Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer must be stages T1-2N2-3 or T3N1-3 or T4N0-3 (American Joint Committee on Cancer [AJCC] version 8); p16-positive oropharynx cancer patients, stages T4N0-3 or T1-3N2-3 (AJCC version 8); The patient has measurable disease as defined by the presence of at least one measurable lesion per RECIST 1.1; Please note: A histological or pathological specimen from cervical lymph nodes with well-defined primary site documented clinically or radiologically is acceptable Clinical stage noted above should be based upon following diagnostic workup: History/physical examination within 30 days prior to registration; Examination by radiation oncologist or medical oncologist or otolaryngology (ENT) or head & neck surgeon 30 days prior to registration, including fiber optic exam with laryngopharyngoscopy; Diagnostic quality computed tomography (CT) or magnetic resonance imaging (MRI) of neck, with contrast, within 30 days prior to registration. Fludeoxyglucose F-18 (18F-FDG) whole body positron emission tomography (PET)-CT scan within 42 days of registration is strongly recommended but does not replace the CT or MRI study. Note: If CT component of the PET/CT is of diagnostic quality then PET/CT can be used for eligibility, however the PET/CT scan must be done within 30 days prior to registration Diagnostic quality, cross sectional imaging of the thorax within 42 days prior to registration; 18-F-FDG-PET/CT or conventional CT are acceptable Age >= 18 years Patients must have a contraindication to cisplatin as defined in the following bullet points. Sites must complete the online tool at comogram.org prior to registration to determine if the patient is eligible. The scores must be recorded on a case report form (CRF). (Refer to data submission table on the NRG-HN008 protocol page on the NRG website); Age >= 70 with moderate to severe comorbidity, defined as having one or more of the following conditions within 30 days prior to registration; Modified Charlson Comorbidity Index >= 1 Adult Comorbidity Evaluation (ACE)-27 Index >= 1 Omega score < 0.80 G-8 score =< 14 Cancer and Aging Research Group (CARG) Toxicity Score >= 30% Cumulative Illness Rating Scale for Geriatrics (CIRS-G) Score >= 4 OR Age < 70 with severe comorbidity, defined as having two or more of the following conditions within 30 days prior to registration; Modified Charlson Comorbidity Index >= 1 ACE-27 Index >= 1 Omega score < 0.80 G-8 score =< 14 CARG Toxicity Score >= 30% CIRS-G Score >= 4 OR Age >= 18 with an absolute or relative contraindication to cisplatin, defined as one or more of the following criterion within 30 days prior to registration: Pre-existing peripheral neuropathy grade >= 1; Creatinine clearance (CrCl) must be > 30 and < 60 mL/min For this calculation, use the Cockcroft-Gault formula History of hearing loss, defined as either: Existing need of a hearing aid OR >= 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated Zubrod Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 30 days prior to registration Whole blood cell (WBC) >= 2000 cells/mm^3 (within 30 days prior to registration) Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to registration) Platelets >= 100,000 cells/mm^3 (within 30 days prior to registration) Hemoglobin >= 9.0 g/dL (within 30 days prior to registration); Note: The use of transfusion is acceptable Creatinine clearance (CrCl) > 30 mL/min (within 30 days prior to registration) Total bilirubin =< 1.5 x upper limit of normal (ULN) (except patients with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL) (within 30 days prior to registration) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (within 30 days prior to registration) For women of child bearing potential (e.g. uterus present and menstruating), a negative serum pregnancy test within 14 days prior to registration. Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL The patient must provide study-specific informed consent prior to study entry Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4 T cell count >= 200 are eligible for this trial. Testing is not required for entry into protocol Patients with a history of hepatitis B or C infection are eligible if they have an undetectable viral load Willing to use highly effective contraceptives for males and females of childbearing potential during therapy and for 12 weeks after the last dose of M3814 (peposertib); this inclusion is necessary because the treatment in this study may be significantly teratogenic Patients must be able to swallow whole tablets Exclusion Criteria: Definitive clinical or radiologic evidence of distant (beyond cervical lymph node and neck tissue) metastatic disease Carcinoma of the neck of unknown primary site origin Patients with oral cavity cancer are excluded from participation if the patient is medically operable and the resection of the primary tumor is considered technically feasible by an oral or head and neck cancer surgical subspecialist Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease Note: Patients with RECIST, version (v.) 1.1 evaluable remaining cancer either in the neck or primary site remain eligible Prior invasive malignancy (except non-melanomatous skin cancer carcinoma, in situ of the breast, oral cavity, or cervix, low or very low-risk prostate cancer) unless disease free for a minimum of 3 years Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if not within =< 3 years Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields Severe, active co-morbidity defined as follows: History of bone marrow transplant and organ transplant, including allogenic stem cell transplantation; Unstable angina requiring hospitalization in the last 6 months; New York Heart Association Functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.); Myocardial infarction within the last 6 months; Persistent grade 3-4 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) electrolyte abnormalities that cannot be reversed despite as indicated by repeat testing; Ongoing active infection that is associated with symptoms and/or requires antibiotic therapy at the time of registration (excluding asymptomatic bacteriuria, genital herpes, oral herpes, thrush, bacterial vaginosis, vaginal candidiasis, topical antifungals) Pregnancy and nursing females, if applicable Concomitant use of proton pump inhibitors (or unable to stop 5 days prior to treatment) Receipt of live vaccinations within 28 days prior to registration Patients unable to discontinue medications or substances that are: Strong inhibitors, inducers or sensitive substrates of CYP3A4/5, CYP2C19, or CYP2C9 prior to study treatment; Substrates of CYP1A2, CYP2B6, or CYP3A4/5 with a narrow therapeutic prior to study treatment; Note: Opioids are allowed, with the exception of methadone Fridericia's correction formula (QTcF) > 450 ms for males and > 470 ms for females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maura L Gillison
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
602-747-9738
First Name & Middle Initial & Last Name & Degree
Michael A. Samuels
Facility Name
Mayo Clinic Hospital in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Panayiotis (Panos) Savvides
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
UACC-IIT@uacc.arizona.edu
First Name & Middle Initial & Last Name & Degree
Ricklie A. Julian
Facility Name
University of Arizona Cancer Center-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
UACC-IIT@uacc.arizona.edu
First Name & Middle Initial & Last Name & Degree
Ricklie A. Julian
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
858-822-5354
Email
cancercto@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Loren K. Mell
Facility Name
Stanford Cancer Institute Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
650-498-7061
Email
ccto-office@stanford.edu
First Name & Middle Initial & Last Name & Degree
Saad A. Khan
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
305-243-2647
First Name & Middle Initial & Last Name & Degree
Stuart E. Samuels
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-679-0775
Email
ClinicalTrials@moffitt.org
First Name & Middle Initial & Last Name & Degree
Jimmy J. Caudell
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-946-7447
First Name & Middle Initial & Last Name & Degree
Soumon Rudra
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Suspended
Facility Name
The James Graham Brown Cancer Center at University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
502-562-3429
First Name & Middle Initial & Last Name & Degree
Rebecca A. Redman
Facility Name
Highland Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
585-341-8113
First Name & Middle Initial & Last Name & Degree
Yuhchyau Chen
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
585-275-5830
First Name & Middle Initial & Last Name & Degree
Yuhchyau Chen
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-293-5066
Email
Jamesline@osumc.edu
First Name & Middle Initial & Last Name & Degree
Priyanka Bhateja
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-271-8777
Email
ou-clinical-trials@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Minh Phan
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
503-215-2614
Email
CanRsrchStudies@providence.org
First Name & Middle Initial & Last Name & Degree
Nitya Alluri
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-312-3320
Email
OncologyClinicTrialsSF@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-312-3320
Email
OncologyClinicalTrialsSF@SanfordHealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Maura L. Gillison
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
703-720-5210
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name & Degree
John F. Deeken

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
IPD Sharing URL
https://grants.nih.gov/policy/sharing.htm

Learn more about this trial

Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin

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