RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer

• ClinicalTrials.gov Identifier: NCT03894215
• Recruitment Status: Active, not recruiting
• First Posted: March 28, 2019
• Last Update Posted: December 7, 2022
• Sponsor: Agenus Inc.
• Collaborator: GOG Foundation
• Information provided by (Responsible Party): Agenus Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer	Drug: AGEN2034; Drug: AGEN1884	Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Two-arm, Randomized, Non-comparative, Phase 2 Trial of AGEN2034 (Anti-PD-1) as a Monotherapy or Combination Therapy With AGEN1884 (Anti- CTLA4) or With Placebo in Women With Recurrent Cervical Cancer (Second Line) - RaPiDS
• Actual Study Start Date: June 1, 2019
• Estimated Primary Completion Date: August 2024
• Estimated Study Completion Date: September 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: AGEN2034 + Placebo; AGEN2034 administered with placebo monotherapy: approximately 100 patients.	Drug: AGEN2034; PD-1 antibody
Experimental: AGEN2034 + AGEN1884; AGEN2034 administered in combination with AGEN1884 (combination therapy): approximately 100 patients.	Drug: AGEN2034; PD-1 antibody; Drug: AGEN1884; CTLA-4 antibody

Outcome Measures

Primary Outcome Measures :

1. Objective Response Rate [ Time Frame: 48 months ]
   To assess the Objective Response Rate (ORR) to the treatment of AGEN2034 (anti-PD-1) administered with placebo (Treatment Arm 1 - monotherapy), or with AGEN1884 (anti-CTLA4) (Treatment Arm 2 - combination therapy), defined as the binomial proportion of intent to treat (ITT) patients with best overall response (BOR) of complete response (CR) or partial response (PR), in women with recurrent/persistent/metastatic cervical cancer who have progressed following first-line therapy. BOR will be determined by the Independent Radiology Review Committee (IRRC), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Secondary Outcome Measures :

1. Frequency, severity and duration of treatment-emergent AEs [ Time Frame: 48 months ]
   To confirm the safety and tolerability of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2 - combination therapy) in patients with recurrent, progressive second-line cervical cancer.
2. DOR per RECIST 1.1 [ Time Frame: 48 months ]
   To assess duration of response (DOR), stable disease (SD), duration of stable disease and disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) per RECIST 1.1 for AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2 - combination therapy).
3. Time to Confirmed Progression [ Time Frame: 48 months ]
   To estimate the time to confirmed progression by the investigator per iRECIST for AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2 - combination therapy).
4. Immunogenicity of AGEN2034 [ Time Frame: 48 months ]
   To evaluate the immunogenicity of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2 - combination therapy) and to correlate it to exposure and biological activity.
5. Maximum observed drug concentration at steady state (Cmax-ss) [ Time Frame: 48 months ]
   To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).
6. Minimum observed drug concentration at steady-state (Cmin-ss) [ Time Frame: 48 months ]
   To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).
7. Area under the concentration-time curve within time span t1 to t2 at steady-state (AUC(τ1-τ2)-ss) [ Time Frame: 48 months ]
   To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).
8. Area under the drug concentration-time curve from time zero to time t (AUC(0-t)) [ Time Frame: 48 months ]
   To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).
9. Area under the drug concentration-time curve from time zero to infinity (AUC(0-∞)) [ Time Frame: 48 months ]
   To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).
10. Time to maximum drug concentration (tmax) [ Time Frame: 48 months ]
    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).
11. Terminal disposition rate constant (λz) [ Time Frame: 48 months ]
    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).
12. Terminal elimination half-life (t1/2) [ Time Frame: 48 months ]
    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).
13. Systemic clearance (CL) [ Time Frame: 48 months ]
    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).
14. Volume of distribution (Vd) [ Time Frame: 48 months ]
    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).
15. Quality of Life Assessment per FACT-Cx [ Time Frame: 35 months ]
    To assess quality of life in the treated population using the Functional Assessment of Cancer Therapy - Cervical Cancer Trial Outcome Index (FACT-Cx)
16. Quality of Life Assessment per BPI [ Time Frame: 35 months ]
    To assess quality of life in the treated population using Brief Pain Inventory (BPI)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Only female
• Accepts Healthy Volunteers: No

Criteria

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.

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States, 35233-1802

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States, 36604

United States, Arizona

Arizona Oncology - Biltmore Cancer Center

Phoenix, Arizona, United States, 85016

Arizona Oncology - Tucson - Wilmot Road Location

Tucson, Arizona, United States, 85711

United States, California

University of California, San Diego (UCSD) - Moores Cancer Center

La Jolla, California, United States, 92093

UCLA- Women's Health Clinical Research Unit (WHCRU)

Los Angeles, California, United States, 90095

Gynecologic Oncology Associates

Newport, California, United States, 92663

California Pacific Medical Center

San Francisco, California, United States, 94115-1821

University of California, San Francisco Medical Center

San Francisco, California, United States, 94158

United States, Florida

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States, 32207

Moffitt Cancer Center

Tampa, Florida, United States, 33612

United States, Georgia

Northside Hospital

Atlanta, Georgia, United States, 30342

St Joseph's Hospital

Savannah, Georgia, United States, 31405-6015

United States, Indiana

Community Health Network - North Cancer Center

Indianapolis, Indiana, United States, 46250

United States, Kentucky

University of Kentucky Albert B. Chandler Hospital

Lexington, Kentucky, United States, 40536

United States, Louisiana

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

United States, New Jersey

MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States, 08103

United States, New Mexico

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States, 87102

United States, New York

Albert Einstein College of Medicine

Bronx, New York, United States, 10461

Northwell Health Monter Cancer Center

Lake Success, New York, United States, 11042

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States, 10016

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

United States, North Carolina

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States, 28374

United States, Ohio

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Columbus NCORP

Columbus, Ohio, United States, 43215

United States, Oklahoma

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73104-5418

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, United States, 74146

United States, Oregon

Willamette Valley Cancer Institute

Eugene, Oregon, United States, 97401

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States, 97227

United States, Pennsylvania

Penn Medicine - Jordan Center for Gynecologic Cancer

Philadelphia, Pennsylvania, United States, 19104-5127

WellSpan Gynecologic Oncology

York, Pennsylvania, United States, 17403

United States, Rhode Island

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States, 02905

United States, Texas

Texas Oncology Surgical Specialists - Austin Central

Austin, Texas, United States, 78745

Texas Oncology - Bedford

Bedford, Texas, United States, 76022

Texas Oncology - Dallas - Presbyterian Cancer Center

Dallas, Texas, United States, 75231

The University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, United States, 76104

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, United States, 78240

Texas Oncology - The Woodlands

The Woodlands, Texas, United States, 77380

Texas Oncology

Tyler, Texas, United States, 75702

Brazil

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil, 60336-045

Hospital Santa Rita

Vitória, Espírito Santo, Brazil, 29043-260

IMIP - Instituto de Medicina Integral Prof. Fernando Figueira

Recife, Pernambuco, Brazil, 50070-902

ONCOSITE/Hospital de Caridade de Ijuí

Ijuí, Rio Grande Do Sul, Brazil, 98700-000

Hospital Mãe de Deus

Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270

CECOR - Centro Oncológico de Roraima

Boa Vista, Roraima, Brazil, 69304-015

Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil, 14784-400

INCA - Instituto Nacional de Câncer

Rio De Janeiro, Brazil, 20231-050

Instituto do Câncer do Estado de São Paulo

São Paulo, Brazil, 01246-000

Perola Centro de Pesquisa em Oncologia

São Paulo, Brazil, 01317-001

Hospital Amaral Carvalho

São Paulo, Brazil, 17210-120

Fundação Antonio Prudente/AC Camargo Cancer Center

São Paulo, Brazil, 9015-010

Korea, Republic of

Seoul National University

Seoul, Korea, Republic of, 03080

Gangnam Severence Hospital

Seoul, Korea, Republic of, 06273

Samsung Medical Center

Seoul, Korea, Republic of

Mexico

COI Centro Oncológico Internacional S.A.P.I. de C.V.

Mexico, Ciudad De Mexico, Mexico, 04700

Christus Muguerza Hospital Vidriera

Monterrey, Nuevo Leon, Mexico, 64570

Oaxaca Site Management Organization (OSMO)

Oaxaca, Mexico, 68000

Cancerologia De Queretaro

Queretaro, Mexico, 76090

Peru

Clinica MonteSur, Centro de Investigación Clínica Montesur RCI -259

Lima Lima, Peru, 15023

Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

Mackay Memorial Hospital Taipei Branch

Taipei, Taiwan, 10449

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan, 11259

Thailand

King Chulalongkorn Memorial Hospital, Chulalongkorn University

Bangkok, Thailand, 10330

Ramathibodi Hospital, Mahidol University

Bangkok, Thailand, 10400

Sponsors and Collaborators

Agenus Inc.

GOG Foundation

Investigators

• Study Director: Medical Director; Agenus Inc.

More Information

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Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.

Carlino, M.S. et al., 2017. KEYNOTE-029: Efficacy and safety of pembrolizumab (pembro) plus ipilimumab (ipi) for advanced melanoma. In ASCO Annual Meeting. Chicago.

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

O'Malley DM, Randall LM, Jackson CG, Coleman RL, Hays JL, Moore KN, Naumann RW, Rocconi RP, Slomovitz BM, Tewari KS, Ancukiewicz M, Feliu WO, Monk BJ. RaPiDS (GOG-3028): randomized Phase II study of balstilimab alone or in combination with zalifrelimab in cervical cancer. Future Oncol. 2021 Sep;17(26):3433-3443. doi: 10.2217/fon-2021-0529. Epub 2021 Aug 19.

• Responsible Party: Agenus Inc.
• ClinicalTrials.gov Identifier: NCT03894215
• Other Study ID Numbers: C-750-01/GOG-3028
• First Posted: March 28, 2019
• Last Update Posted: December 7, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases