RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer
NCT ID: NCT03894215
Last Updated: 2025-02-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
212 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-06-01
Study Completion Date
2026-09-30
Brief Summary
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This is a randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2- combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy. The study is not intended to compare the efficacy of the 2 experimental arms. Rather, the efficacy of each arm will be evaluated against its relevant historical controls as appropriate.
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Detailed Description
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This is a randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2- combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy. The study is not intended to compare the efficacy of the 2 experimental arms. Rather, the efficacy of each arm will be evaluated against its relevant historical controls as appropriate Patients will receive AGEN2034 with placebo as a monotherapy or with AGEN1884 as combination therapy for a maximum of 24 months or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs. Placebo administration in Treatment Arm 1 (AGEN 2034 monotherapy) of the study is intended to preserve the integrity of the investigators' interpretation of the efficacy and safety data by eliminating biases in disease assessment monitoring, declaration of disease progression, and assessment of toxicities. Therefore, it is understood that investigators, patients, and research personnel will not know whether patients have received AGEN2034/placebo (Treatment Arm 1) or AGEN2034/AGEN1884 (Treatment Arm 2).
An Independent Data Monitoring Committee (IDMC) will evaluate safety and efficacy. An IRRC will be established to adjudicate tumor response.
An Independent Data Monitoring Committee (IDMC) will evaluate safety and efficacy. An IRRC will be established to adjudicate tumor response.
Conditions
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Cervical Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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AGEN2034 + Placebo
AGEN2034 administered with placebo monotherapy: approximately 100 patients.
Group Type
EXPERIMENTAL
AGEN2034
Intervention Type
DRUG
PD-1 antibody
AGEN2034 + AGEN1884
AGEN2034 administered in combination with AGEN1884 (combination therapy): approximately 100 patients.
Group Type
EXPERIMENTAL
AGEN2034
Intervention Type
DRUG
PD-1 antibody
AGEN1884
Intervention Type
DRUG
CTLA-4 antibody
Interventions
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AGEN2034
PD-1 antibody
Intervention Type
DRUG
AGEN1884
CTLA-4 antibody
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Voluntarily agree to participate by giving written informed consent. (Participation in pharmacogenomics testing is optional).
2. Be ≥18 years of age.
3. Diagnosis:
1. Have (1) a histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, and (2) metastatic, locally advanced, and/or unresectable disease at the time of enrollment. Histologic confirmation of the original primary tumor is required via pathology report.
Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma, and mesonephric carcinoma.
2. Has cervical cancer and has relapsed after a platinum- based treatment (first line) regimen for advanced (recurrent, unresectable, or metastatic) disease.
4. Measurable Disease:
a. Have measurable disease on imaging based on RECIST version 1.1 by Investigator assessments and independent central radiologic review.
Note: Patients without centrally confirmed measurable disease at baseline will not be eligible for this trial.
Note: Patients must have at least 1 "target lesion" to be used to assess response, as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
5. Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Have adequate organ function as indicated by the following laboratory values:
1. Adequate hematological function defined by absolute neutrophil count (ANC) \> 1.5 x 10\^9/L, platelet count \> 100 x 10\^9/L, and hemoglobin \>8 g/dL (without transfusions within 1 week of first dose).
2. Adequate hepatic function based by a total bilirubin level ≤ 1.5 the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) level ≤ 2.5 x IULN, alanine aminotransferase (ALT) level ≤ 2.5 x IULN, and alkaline phosphatase ≤ 2.5 IULN and albumin ≥3.0 mg/dL.
3. Adequate renal function defined as creatinine ≤ 1.5 × upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 40 mL/minute per Institutional standard. Assessment methods should be recorded.
4. Adequate coagulation defined by international normalized ratio (INR) or prothrombin time ≤ 1.5 x IULN (unless the patient is receiving anticoagulant therapy); and activated partial thromboplastin time (aPTT) ≤ 1.5 x IULN (unless the patient is receiving anticoagulant therapy)
7. Has no history of another primary malignancy, with the exception of:
1. Malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of study drug and of low potential risk for recurrence.
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease and superficial bladder cancer.
8. Patients must provide a sufficient and adequate FFPE tumor tissue sample preferably from the most recent biopsy of a tumor lesion, collected either at the time of or after the diagnosis of advanced or metastatic disease has been made AND from a site not previously irradiated. Archival tumor tissue must be ≤ 3 years old. If no tumor tissue is available, a fresh biopsy will be required (See Section 7.2.3.1 for details).
Note: Tissue from core biopsy or excisional biopsy or from resection is required.
9. Patients must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication) if of childbearing potential or be of non-childbearing potential. Non-childbearing potential is defined as (by other than medical reasons):
1. ≥45 years of age and has not had menses for greater than 1 year,
2. Amenorrheic ≥ 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation,
3. History of hysterectomy, oophorectomy or tubal ligation.
4. Definitive pelvic radiation for the treatment of cervical cancer.
10. If of childbearing potential, female patients must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
11. Is willing and able to comply with the requirements of the protocol.
2. Be ≥18 years of age.
3. Diagnosis:
1. Have (1) a histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, and (2) metastatic, locally advanced, and/or unresectable disease at the time of enrollment. Histologic confirmation of the original primary tumor is required via pathology report.
Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma, and mesonephric carcinoma.
2. Has cervical cancer and has relapsed after a platinum- based treatment (first line) regimen for advanced (recurrent, unresectable, or metastatic) disease.
4. Measurable Disease:
a. Have measurable disease on imaging based on RECIST version 1.1 by Investigator assessments and independent central radiologic review.
Note: Patients without centrally confirmed measurable disease at baseline will not be eligible for this trial.
Note: Patients must have at least 1 "target lesion" to be used to assess response, as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
5. Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Have adequate organ function as indicated by the following laboratory values:
1. Adequate hematological function defined by absolute neutrophil count (ANC) \> 1.5 x 10\^9/L, platelet count \> 100 x 10\^9/L, and hemoglobin \>8 g/dL (without transfusions within 1 week of first dose).
2. Adequate hepatic function based by a total bilirubin level ≤ 1.5 the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) level ≤ 2.5 x IULN, alanine aminotransferase (ALT) level ≤ 2.5 x IULN, and alkaline phosphatase ≤ 2.5 IULN and albumin ≥3.0 mg/dL.
3. Adequate renal function defined as creatinine ≤ 1.5 × upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 40 mL/minute per Institutional standard. Assessment methods should be recorded.
4. Adequate coagulation defined by international normalized ratio (INR) or prothrombin time ≤ 1.5 x IULN (unless the patient is receiving anticoagulant therapy); and activated partial thromboplastin time (aPTT) ≤ 1.5 x IULN (unless the patient is receiving anticoagulant therapy)
7. Has no history of another primary malignancy, with the exception of:
1. Malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of study drug and of low potential risk for recurrence.
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease and superficial bladder cancer.
8. Patients must provide a sufficient and adequate FFPE tumor tissue sample preferably from the most recent biopsy of a tumor lesion, collected either at the time of or after the diagnosis of advanced or metastatic disease has been made AND from a site not previously irradiated. Archival tumor tissue must be ≤ 3 years old. If no tumor tissue is available, a fresh biopsy will be required (See Section 7.2.3.1 for details).
Note: Tissue from core biopsy or excisional biopsy or from resection is required.
9. Patients must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication) if of childbearing potential or be of non-childbearing potential. Non-childbearing potential is defined as (by other than medical reasons):
1. ≥45 years of age and has not had menses for greater than 1 year,
2. Amenorrheic ≥ 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation,
3. History of hysterectomy, oophorectomy or tubal ligation.
4. Definitive pelvic radiation for the treatment of cervical cancer.
10. If of childbearing potential, female patients must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
11. Is willing and able to comply with the requirements of the protocol.
Exclusion Criteria
The patient must be excluded from participating in the trial if the patient:
1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of treatment.
2. Has an inadequate washout period prior to first dose of study drug defined as:
1. Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose,
2. Received radiation therapy within 3 weeks before first dose, or
3. Had major surgery within 4 weeks before first dose.
3. Has received prior therapy with:
1. Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti- cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies
2. More than 1 systemic treatment regimen for the advanced (recurrent, unresectable, or metastatic) cervical cancer for which the patient is considered for the study.
4. Has persisting toxicity related to prior therapy of National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE) Grade \>1 severity.
Note: Sensory neuropathy or alopecia of Grade ≤2 is acceptable.
5. Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).
6. Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI-CTCAE Grade ≥3), any history of anaphylaxis, or uncontrolled asthma.
7. Has received systemic corticosteroid therapy ≤ 7 days prior to the first dose of trial treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on study for management of immune-related adverse events (AE), and/or a premedication for IV contrast allergies/reactions is allowed). Patients who are receiving daily corticosteroid replacement therapy are an exception to this rule. Daily prednisone at doses of up to 5 mg or equivalent hydrocortisone dose are examples of permitted replacement therapy.
8. Has a central nervous system (CNS) tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period OR identified prior to consent.
Note: Patients with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images, performed ≥ 4 weeks apart, and obtained after the brain metastases treatment). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as sequelae from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued ≥ 7 days prior to first dose of study drug.
9. Has active or history of autoimmune disease that has required immunosuppressive systemic treatment within 2 years of the start of trial treatment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of immunosuppressive systemic treatment.
Note: Patients with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
10. Has had an allogeneic tissue/solid organ transplant.
11. Has or had interstitial lung disease (ILD) OR has had a history of pneumonitis that has required oral or IV corticosteroids.
12. Has an active infection requiring intravenous (IV) systemic therapy.
13. Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
14. Has known active Hepatitis B (HBV), Hepatitis C (HCV), or tuberculosis. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay.
15. Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥II), or serious uncontrolled cardiac arrhythmia requiring medication.
16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
18. Is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol). Medicinal marijuana use is not considered "illicit" and is allowed to be utilized prior to and during enrollment.
19. Is legally incapacitated or has limited legal capacity.
20. Is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of the study drug.
1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of treatment.
2. Has an inadequate washout period prior to first dose of study drug defined as:
1. Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose,
2. Received radiation therapy within 3 weeks before first dose, or
3. Had major surgery within 4 weeks before first dose.
3. Has received prior therapy with:
1. Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti- cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies
2. More than 1 systemic treatment regimen for the advanced (recurrent, unresectable, or metastatic) cervical cancer for which the patient is considered for the study.
4. Has persisting toxicity related to prior therapy of National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE) Grade \>1 severity.
Note: Sensory neuropathy or alopecia of Grade ≤2 is acceptable.
5. Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).
6. Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI-CTCAE Grade ≥3), any history of anaphylaxis, or uncontrolled asthma.
7. Has received systemic corticosteroid therapy ≤ 7 days prior to the first dose of trial treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on study for management of immune-related adverse events (AE), and/or a premedication for IV contrast allergies/reactions is allowed). Patients who are receiving daily corticosteroid replacement therapy are an exception to this rule. Daily prednisone at doses of up to 5 mg or equivalent hydrocortisone dose are examples of permitted replacement therapy.
8. Has a central nervous system (CNS) tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period OR identified prior to consent.
Note: Patients with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images, performed ≥ 4 weeks apart, and obtained after the brain metastases treatment). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as sequelae from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued ≥ 7 days prior to first dose of study drug.
9. Has active or history of autoimmune disease that has required immunosuppressive systemic treatment within 2 years of the start of trial treatment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of immunosuppressive systemic treatment.
Note: Patients with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
10. Has had an allogeneic tissue/solid organ transplant.
11. Has or had interstitial lung disease (ILD) OR has had a history of pneumonitis that has required oral or IV corticosteroids.
12. Has an active infection requiring intravenous (IV) systemic therapy.
13. Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
14. Has known active Hepatitis B (HBV), Hepatitis C (HCV), or tuberculosis. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay.
15. Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥II), or serious uncontrolled cardiac arrhythmia requiring medication.
16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
18. Is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol). Medicinal marijuana use is not considered "illicit" and is allowed to be utilized prior to and during enrollment.
19. Is legally incapacitated or has limited legal capacity.
20. Is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of the study drug.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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GOG Foundation
NETWORK
Sponsor Role
collaborator
Agenus Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Agenus Inc.
Locations
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University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States
Site Status
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Site Status
Arizona Oncology - Biltmore Cancer Center
Phoenix, Arizona, United States
Site Status
Arizona Oncology - Tucson - Wilmot Road Location
Tucson, Arizona, United States
Site Status
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States
Site Status
UCLA- Women's Health Clinical Research Unit (WHCRU)
Los Angeles, California, United States
Site Status
Gynecologic Oncology Associates
Newport, California, United States
Site Status
California Pacific Medical Center
San Francisco, California, United States
Site Status
University of California, San Francisco Medical Center
San Francisco, California, United States
Site Status
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Site Status
Moffitt Cancer Center
Tampa, Florida, United States
Site Status
Northside Hospital
Atlanta, Georgia, United States
Site Status
St Joseph's Hospital
Savannah, Georgia, United States
Site Status
Community Health Network - North Cancer Center
Indianapolis, Indiana, United States
Site Status
University of Kentucky Albert B. Chandler Hospital
Lexington, Kentucky, United States
Site Status
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Site Status
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States
Site Status
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Site Status
Northwell Health Monter Cancer Center
Lake Success, New York, United States
Site Status
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Site Status
SUNY Upstate Medical University
Syracuse, New York, United States
Site Status
Albert Einstein College of Medicine
The Bronx, New York, United States
Site Status
Levine Cancer Institute
Charlotte, North Carolina, United States
Site Status
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, United States
Site Status
MetroHealth Medical Center
Cleveland, Ohio, United States
Site Status
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Site Status
Columbus NCORP
Columbus, Ohio, United States
Site Status
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Site Status
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States
Site Status
Willamette Valley Cancer Institute
Eugene, Oregon, United States
Site Status
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Site Status
Penn Medicine - Jordan Center for Gynecologic Cancer
Philadelphia, Pennsylvania, United States
Site Status
WellSpan Gynecologic Oncology
York, Pennsylvania, United States
Site Status
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Site Status
Texas Oncology Surgical Specialists - Austin Central
Austin, Texas, United States
Site Status
Texas Oncology - Bedford
Bedford, Texas, United States
Site Status
Texas Oncology - Dallas - Presbyterian Cancer Center
Dallas, Texas, United States
Site Status
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Site Status
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, United States
Site Status
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
Site Status
Texas Oncology - The Woodlands
The Woodlands, Texas, United States
Site Status
Texas Oncology
Tyler, Texas, United States
Site Status
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Site Status
Hospital Santa Rita
Vitória, Espírito Santo, Brazil
Site Status
IMIP - Instituto de Medicina Integral Prof. Fernando Figueira
Recife, Pernambuco, Brazil
Site Status
ONCOSITE/Hospital de Caridade de Ijuí
Ijuí, Rio Grande do Sul, Brazil
Site Status
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
CECOR - Centro Oncológico de Roraima
Boa Vista, Roraima, Brazil
Site Status
Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Site Status
INCA - Instituto Nacional de Câncer
Rio de Janeiro, , Brazil
Site Status
Instituto do Câncer do Estado de São Paulo
São Paulo, , Brazil
Site Status
Perola Centro de Pesquisa em Oncologia
São Paulo, , Brazil
Site Status
Hospital Amaral Carvalho
São Paulo, , Brazil
Site Status
Fundação Antonio Prudente/AC Camargo Cancer Center
São Paulo, , Brazil
Site Status
COI Centro Oncológico Internacional S.A.P.I. de C.V.
Mexico City, Mexico City, Mexico
Site Status
Christus Muguerza Hospital Vidriera
Monterrey, Nuevo León, Mexico
Site Status
Oaxaca Site Management Organization (OSMO)
Oaxaca City, , Mexico
Site Status
Cancerologia De Queretaro
Querétaro, , Mexico
Site Status
Clinica MonteSur, Centro de Investigación Clínica Montesur RCI -259
Lima Lima, , Peru
Site Status
Seoul National University
Seoul, , South Korea
Site Status
Gangnam Severence Hospital
Seoul, , South Korea
Site Status
Samsung Medical Center
Seoul, , South Korea
Site Status
Taichung Veterans General Hospital
Taichung, , Taiwan
Site Status
Mackay Memorial Hospital Taipei Branch
Taipei, , Taiwan
Site Status
Taipei Veterans General Hospital
Taipei, , Taiwan
Site Status
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, , Taiwan
Site Status
King Chulalongkorn Memorial Hospital, Chulalongkorn University
Bangkok, , Thailand
Site Status
Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Site Status
Countries
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United States
Brazil
Mexico
Peru
South Korea
Taiwan
Thailand
References
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Allie SR, Zhang W, Fuse S, Usherwood EJ. Programmed death 1 regulates development of central memory CD8 T cells after acute viral infection. J Immunol. 2011 Jun 1;186(11):6280-6. doi: 10.4049/jimmunol.1003870. Epub 2011 Apr 27.
Reference Type
RESULT
Antonia S, Goldberg SB, Balmanoukian A, Chaft JE, Sanborn RE, Gupta A, Narwal R, Steele K, Gu Y, Karakunnel JJ, Rizvi NA. Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study. Lancet Oncol. 2016 Mar;17(3):299-308. doi: 10.1016/S1470-2045(15)00544-6. Epub 2016 Feb 6.
Reference Type
RESULT
Antonia SJ, Lopez-Martin JA, Bendell J, Ott PA, Taylor M, Eder JP, Jager D, Pietanza MC, Le DT, de Braud F, Morse MA, Ascierto PA, Horn L, Amin A, Pillai RN, Evans J, Chau I, Bono P, Atmaca A, Sharma P, Harbison CT, Lin CS, Christensen O, Calvo E. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial. Lancet Oncol. 2016 Jul;17(7):883-895. doi: 10.1016/S1470-2045(16)30098-5. Epub 2016 Jun 4.
Reference Type
RESULT
Barber DL, Wherry EJ, Masopust D, Zhu B, Allison JP, Sharpe AH, Freeman GJ, Ahmed R. Restoring function in exhausted CD8 T cells during chronic viral infection. Nature. 2006 Feb 9;439(7077):682-7. doi: 10.1038/nature04444. Epub 2005 Dec 28.
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Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C-750-01/GOG-3028
Identifier Type: -
Identifier Source: org_study_id
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