Spots Global Cancer Trial Database for RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer
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Trial Identification
Brief Title: RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer
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
Study ID: NCT03894215
Conditions
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.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
Arizona Oncology - Biltmore Cancer Center, Phoenix, Arizona, United States
Arizona Oncology - Tucson - Wilmot Road Location, Tucson, Arizona, United States
University of California, San Diego (UCSD) - Moores Cancer Center, La Jolla, California, United States
UCLA- Women's Health Clinical Research Unit (WHCRU), Los Angeles, California, United States
Gynecologic Oncology Associates, Newport, California, United States
California Pacific Medical Center, San Francisco, California, United States
University of California, San Francisco Medical Center, San Francisco, California, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
St Joseph's Hospital, Savannah, Georgia, United States
Community Health Network - North Cancer Center, Indianapolis, Indiana, United States
University of Kentucky Albert B. Chandler Hospital, Lexington, Kentucky, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Albert Einstein College of Medicine, Bronx, New York, United States
Northwell Health Monter Cancer Center, Lake Success, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
FirstHealth Outpatient Cancer Center, Pinehurst, North Carolina, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Columbus NCORP, Columbus, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa, Oklahoma, United States
Willamette Valley Cancer Institute, Eugene, Oregon, United States
Northwest Cancer Specialists, P.C., Portland, Oregon, United States
Penn Medicine - Jordan Center for Gynecologic Cancer, Philadelphia, Pennsylvania, United States
WellSpan Gynecologic Oncology, York, Pennsylvania, United States
Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States
Texas Oncology Surgical Specialists - Austin Central, Austin, Texas, United States
Texas Oncology - Bedford, Bedford, Texas, United States
Texas Oncology - Dallas - Presbyterian Cancer Center, Dallas, Texas, United States
The University of Texas Southwestern Medical Center, Dallas, Texas, United States
Texas Oncology - Fort Worth Cancer Center, Fort Worth, Texas, United States
Texas Oncology - San Antonio Medical Center, San Antonio, Texas, United States
Texas Oncology - The Woodlands, The Woodlands, Texas, United States
Texas Oncology, Tyler, Texas, United States
CRIO - Centro Regional Integrado de Oncologia, Fortaleza, Ceará, Brazil
Hospital Santa Rita, Vitória, Espírito Santo, Brazil
IMIP - Instituto de Medicina Integral Prof. Fernando Figueira, Recife, Pernambuco, Brazil
ONCOSITE/Hospital de Caridade de Ijuí, Ijuí, Rio Grande Do Sul, Brazil
Hospital Mãe de Deus, Porto Alegre, Rio Grande Do Sul, Brazil
CECOR - Centro Oncológico de Roraima, Boa Vista, Roraima, Brazil
Hospital de Câncer de Barretos, Barretos, São Paulo, Brazil
INCA - Instituto Nacional de Câncer, Rio De Janeiro, , Brazil
Instituto do Câncer do Estado de São Paulo, São Paulo, , Brazil
Perola Centro de Pesquisa em Oncologia, São Paulo, , Brazil
Hospital Amaral Carvalho, São Paulo, , Brazil
Fundação Antonio Prudente/AC Camargo Cancer Center, São Paulo, , Brazil
Seoul National University, Seoul, , Korea, Republic of
Gangnam Severence Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
COI Centro Oncológico Internacional S.A.P.I. de C.V., Mexico, Ciudad De Mexico, Mexico
Christus Muguerza Hospital Vidriera, Monterrey, Nuevo Leon, Mexico
Oaxaca Site Management Organization (OSMO), Oaxaca, , Mexico
Cancerologia De Queretaro, Queretaro, , Mexico
Clinica MonteSur, Centro de Investigación Clínica Montesur RCI -259, Lima Lima, , Peru
Taichung Veterans General Hospital, Taichung, , Taiwan
Mackay Memorial Hospital Taipei Branch, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, , Thailand
Ramathibodi Hospital, Mahidol University, Bangkok, , Thailand
Contact Details
Name: Medical Director
Affiliation: Agenus Inc.
Role: STUDY_DIRECTOR
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