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Cervical CancerPhase 2NCT03894215

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

A Phase 2 study testing AGEN2034 and AGEN1884 in people with Cervical Cancer, run by Agenus Inc. at 68 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
AGEN2034 and AGEN1884
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
68 sitesin 7 countries
Study dates
1 Jun 2019to 26 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily agree to participate by giving written informed consent. (Participation in pharmacogenomics testing is optional).
  • Be ≥18 years of age.
  • Diagnosis:
  • 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.
  • Has cervical cancer and has relapsed after a platinum- based treatment (first line) regimen for advanced (recurrent, unresectable, or metastatic) disease.
Show all 28Show fewer
  • Measurable Disease:
  • 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.
  • Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Have adequate organ function as indicated by the following laboratory values:
  • 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).
  • 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.
  • 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.
  • 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)
  • Has no history of another primary malignancy, with the exception of:
  • 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.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease and superficial bladder cancer.
  • 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.
  • 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):
  • ≥45 years of age and has not had menses for greater than 1 year,
  • Amenorrheic ≥ 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation,
  • History of hysterectomy, oophorectomy or tubal ligation.
  • Definitive pelvic radiation for the treatment of cervical cancer.
  • 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.
  • Is willing and able to comply with the requirements of the protocol.

Who cannot join

  • The patient must be excluded from participating in the trial if the patient:
  • 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.
  • Has an inadequate washout period prior to first dose of study drug defined as:
  • Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose,
  • Received radiation therapy within 3 weeks before first dose, or
  • Had major surgery within 4 weeks before first dose.
Show all 29Show fewer
  • Has received prior therapy with:
  • 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
  • More than 1 systemic treatment regimen for the advanced (recurrent, unresectable, or metastatic) cervical cancer for which the patient is considered for the study.
  • 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.
  • 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).
  • Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI-CTCAE Grade ≥3), any history of anaphylaxis, or uncontrolled asthma.
  • 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.
  • 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.
  • 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.
  • Has had an allogeneic tissue/solid organ transplant.
  • Has or had interstitial lung disease (ILD) OR has had a history of pneumonitis that has required oral or IV corticosteroids.
  • Has an active infection requiring intravenous (IV) systemic therapy.
  • Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • 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.
  • 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.
  • 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.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • 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.
  • Is legally incapacitated or has limited legal capacity.
  • 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.

Trial locations and contacts

68 sites in 7 countries.

68 sites in 7 countries

United States42 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Texas Oncology Surgical Specialists - Austin Central

    Austin, Texas, 78745

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • University of Alabama at Birmingham School of Medicine

    Birmingham, Alabama, 35233-1802

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Columbus NCORP

    Columbus, Ohio, 43215

  • Texas Oncology - Dallas - Presbyterian Cancer Center

    Dallas, Texas, 75231

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Willamette Valley Cancer Institute

    Eugene, Oregon, 97401

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Community Health Network - North Cancer Center

    Indianapolis, Indiana, 46250

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

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

    La Jolla, California, 92093

  • Northwell Health Monter Cancer Center

    Lake Success, New York, 11042

  • University of Kentucky Albert B. Chandler Hospital

    Lexington, Kentucky, 40536

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

    Los Angeles, California, 90095

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Gynecologic Oncology Associates

    Newport, California, 92663

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104-5418

  • Penn Medicine - Jordan Center for Gynecologic Cancer

    Philadelphia, Pennsylvania, 19104-5127

  • Arizona Oncology - Biltmore Cancer Center

    Phoenix, Arizona, 85016

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

  • California Pacific Medical Center

    San Francisco, California, 94115-1821

  • University of California, San Francisco Medical Center

    San Francisco, California, 94158

  • St Joseph's Hospital

    Savannah, Georgia, 31405-6015

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Texas Oncology - The Woodlands

    The Woodlands, Texas, 77380

  • Arizona Oncology - Tucson - Wilmot Road Location

    Tucson, Arizona, 85711

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

  • Texas Oncology

    Tyler, Texas, 75702

  • WellSpan Gynecologic Oncology

    York, Pennsylvania, 17403

Other trials in United States

Brazil12 sites

  • Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • CECOR - Centro Oncológico de Roraima

    Boa Vista, Roraima, 69304-015

  • CRIO - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-045

  • ONCOSITE/Hospital de Caridade de Ijuí

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul, 90110-270

  • IMIP - Instituto de Medicina Integral Prof. Fernando Figueira

    Recife, Pernambuco, 50070-902

  • INCA - Instituto Nacional de Câncer

    Rio de Janeiro, 20231-050

  • Instituto do Câncer do Estado de São Paulo

    São Paulo, 01246-000

  • Perola Centro de Pesquisa em Oncologia

    São Paulo, 01317-001

  • Hospital Amaral Carvalho

    São Paulo, 17210-120

  • Fundação Antonio Prudente/AC Camargo Cancer Center

    São Paulo, 9015-010

  • Hospital Santa Rita

    Vitória, Espírito Santo, 29043-260

Other trials in Brazil

Mexico4 sites

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

    Mexico City, Mexico City, 04700

  • Christus Muguerza Hospital Vidriera

    Monterrey, Nuevo León, 64570

  • Oaxaca Site Management Organization (OSMO)

    Oaxaca City, 68000

  • Cancerologia De Queretaro

    Querétaro, 76090

Other trials in Mexico

Taiwan4 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Mackay Memorial Hospital Taipei Branch

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 11259

Other trials in Taiwan

South Korea3 sites

  • Seoul National University

    Seoul, 03080

  • Gangnam Severence Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul

Other trials in South Korea

Thailand2 sites

  • King Chulalongkorn Memorial Hospital, Chulalongkorn University

    Bangkok, 10330

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

Other trials in Thailand

Peru1 site

  • Clinica MonteSur, Centro de Investigación Clínica Montesur RCI -259

    Lima Lima, 15023

Other trials in Peru

About this study

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

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.

Read the 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.

Conditions
Cervical Cancer
Being tested
AGEN2034, AGEN1884
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGEN2034Drug

    PD-1 antibody

  • AGEN1884Drug

    CTLA-4 antibody

Study groups in NCT03894215
Study groupRoleWhat they receive
AGEN2034 + PlaceboExperimentalAGEN2034 administered with placebo monotherapy: approximately 100 patients.
Receives: Drug: AGEN2034
AGEN2034 + AGEN1884ExperimentalAGEN2034 administered in combination with AGEN1884 (combination therapy): approximately 100 patients.
Receives: Drug: AGEN2034; Drug: AGEN1884

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    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).

    Measured: 48 months

Secondary outcomes (16)

  1. Frequency, severity and duration of treatment-emergent AEs

    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.

    Measured: 48 months

  2. DOR per RECIST 1.1

    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).

    Measured: 48 months

  3. Time to Confirmed Progression

    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).

    Measured: 48 months

  4. Immunogenicity of AGEN2034

    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.

    Measured: 48 months

  5. Maximum observed drug concentration at steady state (Cmax-ss)

    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

    Measured: 48 months

  6. Minimum observed drug concentration at steady-state (Cmin-ss)

    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

    Measured: 48 months

  7. Area under the concentration-time curve within time span t1 to t2 at steady-state (AUC(τ1-τ2)-ss)

    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

    Measured: 48 months

  8. Area under the drug concentration-time curve from time zero to time t (AUC(0-t))

    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

    Measured: 48 months

  9. Area under the drug concentration-time curve from time zero to infinity (AUC(0-∞))

    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

    Measured: 48 months

  10. Time to maximum drug concentration (tmax)

    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

    Measured: 48 months

  11. Terminal disposition rate constant (λz)

    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

    Measured: 48 months

  12. Terminal elimination half-life (t1/2)

    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

    Measured: 48 months

  13. Systemic clearance (CL)

    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

    Measured: 48 months

  14. Volume of distribution (Vd)

    To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

    Measured: 48 months

  15. Quality of Life Assessment per FACT-Cx

    To assess quality of life in the treated population using the Functional Assessment of Cancer Therapy - Cervical Cancer Trial Outcome Index (FACT-Cx)

    Measured: 35 months

  16. Quality of Life Assessment per BPI

    To assess quality of life in the treated population using Brief Pain Inventory (BPI)

    Measured: 35 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2019
  2. Study start1 Jun 2019
  3. Primary completion26 Mar 2025
  4. Study completion26 Mar 2025

Why it stopped: Sponsor strategic decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03894215
Sponsor's protocol ID
C-750-01/GOG-3028
Status last verified
Mar 2026
First submitted
19 Mar 2019
Last updated
27 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Publications

  • 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.

    PubMed 21525385

  • 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.

    PubMed 26858122

  • 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.

    PubMed 27269741

  • 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.

    PubMed 16382236

  • Borcoman E, Le Tourneau C. Pembrolizumab in cervical cancer: latest evidence and clinical usefulness. Ther Adv Med Oncol. 2017 Jun;9(6):431-439. doi: 10.1177/1758834017708742. Epub 2017 May 8.

    PubMed 28607581

  • Boutros C, Tarhini A, Routier E, Lambotte O, Ladurie FL, Carbonnel F, Izzeddine H, Marabelle A, Champiat S, Berdelou A, Lanoy E, Texier M, Libenciuc C, Eggermont AM, Soria JC, Mateus C, Robert C. Safety profiles of anti-CTLA-4 and anti-PD-1 antibodies alone and in combination. Nat Rev Clin Oncol. 2016 Aug;13(8):473-86. doi: 10.1038/nrclinonc.2016.58. Epub 2016 May 4.

    PubMed 27141885

  • Bristol-Myers Squibb USA, 2017a. Opdivo® (nivolumab) package insert,

  • Bristol-Myers Squibb USA, 2017b. Yervoy® (ipilimumab) package insert,

  • Buchbinder EI, Desai A. CTLA-4 and PD-1 Pathways: Similarities, Differences, and Implications of Their Inhibition. Am J Clin Oncol. 2016 Feb;39(1):98-106. doi: 10.1097/COC.0000000000000239.

    PubMed 26558876

  • Bulliard Y, Jolicoeur R, Windman M, Rue SM, Ettenberg S, Knee DA, Wilson NS, Dranoff G, Brogdon JL. Activating Fc gamma receptors contribute to the antitumor activities of immunoregulatory receptor-targeting antibodies. J Exp Med. 2013 Aug 26;210(9):1685-93. doi: 10.1084/jem.20130573. Epub 2013 Jul 29.

    PubMed 23897982

  • Callahan MK, Wolchok JD, Allison JP. Anti-CTLA-4 antibody therapy: immune monitoring during clinical development of a novel immunotherapy. Semin Oncol. 2010 Oct;37(5):473-84. doi: 10.1053/j.seminoncol.2010.09.001.

    PubMed 21074063

  • Camacho LH. CTLA-4 blockade with ipilimumab: biology, safety, efficacy, and future considerations. Cancer Med. 2015 May;4(5):661-72. doi: 10.1002/cam4.371. Epub 2015 Jan 25.

    PubMed 25619164

  • 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.

    PubMed 28636851

  • 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.

  • Chand D, Savistky D, Gonzalez A,, et al. [Abstract]. J Immunother Cancer. 2017;5(Suppl2):P312.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AGEN2034 and AGEN1884 in people with Cervical Cancer, run by Agenus Inc. at 68 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Brazil, Mexico, Taiwan, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor strategic decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03894215, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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