Immunotherapy combo shows promise for advanced cervical cancer

NCT ID NCT03894215

Disease control Sponsor: Agenus Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested two immunotherapy drugs, AGEN2034 and AGEN1884, in 211 women with recurrent cervical cancer that had progressed after chemotherapy. One group received AGEN2034 alone, the other received both drugs. The goal was to see if the tumors shrank. The study was terminated early, so results are limited, but it may help guide future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: AGEN2034 (an immunotherapy drug that helps the immune system attack cancer) and AGEN1884 (another immunotherapy drug that boosts immune response)
What this could lead to: If successful, this could point toward a new treatment option for women with recurrent cervical cancer that has not responded to chemotherapy.
What could go wrong: The trial was terminated early, so results are limited. Immunotherapy can cause immune-related side effects, and not all patients respond. The study was small and not designed to compare the two treatments directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

211 people

The number who actually took part.

Started

Jun 2019

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer

Contacts and locations

Locations

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States
Arizona Oncology - Biltmore Cancer Center

Phoenix, Arizona, 85016, United States
Arizona Oncology - Tucson - Wilmot Road Location

Tucson, Arizona, 85711, United States
Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States
CECOR - Centro Oncológico de Roraima

Boa Vista, Roraima, 69304-015, Brazil
COI Centro Oncológico Internacional S.A.P.I. de C.V.

Mexico City, Mexico City, 04700, Mexico
CRIO - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60336-045, Brazil
California Pacific Medical Center

San Francisco, California, 94115-1821, United States
Cancerologia De Queretaro

Querétaro, 76090, Mexico
Christus Muguerza Hospital Vidriera

Monterrey, Nuevo León, 64570, Mexico
Clinica MonteSur, Centro de Investigación Clínica Montesur RCI -259

Lima Lima, 15023, Peru
Columbus NCORP

Columbus, Ohio, 43215, United States
Community Health Network - North Cancer Center

Indianapolis, Indiana, 46250, United States
FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, 28374, United States
Fundação Antonio Prudente/AC Camargo Cancer Center

São Paulo, 9015-010, Brazil
Gangnam Severence Hospital

Seoul, 06273, South Korea
Gynecologic Oncology Associates

Newport, California, 92663, United States
Hospital Amaral Carvalho

São Paulo, 17210-120, Brazil
Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Hospital Santa Rita

Vitória, Espírito Santo, 29043-260, Brazil
Hospital de CÃ¢ncer de Barretos

Barretos, São Paulo, 14784-400, Brazil
IMIP - Instituto de Medicina Integral Prof. Fernando Figueira

Recife, Pernambuco, 50070-902, Brazil
INCA - Instituto Nacional de Câncer

Rio de Janeiro, 20231-050, Brazil
Instituto do Câncer do Estado de São Paulo

São Paulo, 01246-000, Brazil
King Chulalongkorn Memorial Hospital, Chulalongkorn University

Bangkok, 10330, Thailand
Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 11259, Taiwan
Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States
Levine Cancer Institute

Charlotte, North Carolina, 28204, United States
MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States
Mackay Memorial Hospital Taipei Branch

Taipei, 10449, Taiwan
MetroHealth Medical Center

Cleveland, Ohio, 44109, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
Northside Hospital

Atlanta, Georgia, 30342, United States
Northwell Health Monter Cancer Center

Lake Success, New York, 11042, United States
Northwest Cancer Specialists, P.C.

Portland, Oregon, 97227, United States
ONCOSITE/Hospital de Caridade de Ijuí

Ijuí, Rio Grande do Sul, 98700-000, Brazil
Oaxaca Site Management Organization (OSMO)

Oaxaca City, 68000, Mexico
Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States
Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States
Penn Medicine - Jordan Center for Gynecologic Cancer

Philadelphia, Pennsylvania, 19104-5127, United States
Perola Centro de Pesquisa em Oncologia

São Paulo, 01317-001, Brazil
Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand
SUNY Upstate Medical University

Syracuse, New York, 13210, United States
Samsung Medical Center

Seoul, South Korea
Seoul National University

Seoul, 03080, South Korea
St Joseph's Hospital

Savannah, Georgia, 31405-6015, United States
Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104-5418, United States
Taichung Veterans General Hospital

Taichung, 40705, Taiwan
Taipei Veterans General Hospital

Taipei, 11217, Taiwan
Texas Oncology

Tyler, Texas, 75702, United States
Texas Oncology - Bedford

Bedford, Texas, 76022, United States
Texas Oncology - Dallas - Presbyterian Cancer Center

Dallas, Texas, 75231, United States
Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, 76104, United States
Texas Oncology - San Antonio Medical Center

San Antonio, Texas, 78240, United States
Texas Oncology - The Woodlands

The Woodlands, Texas, 77380, United States
Texas Oncology Surgical Specialists - Austin Central

Austin, Texas, 78745, United States
The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States
The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
UCLA- Women's Health Clinical Research Unit (WHCRU)

Los Angeles, California, 90095, United States
University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, 35233-1802, United States
University of California, San Diego (UCSD) - Moores Cancer Center

La Jolla, California, 92093, United States
University of California, San Francisco Medical Center

San Francisco, California, 94158, United States
University of Kentucky Albert B. Chandler Hospital

Lexington, Kentucky, 40536, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States
University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36604, United States
WellSpan Gynecologic Oncology

York, Pennsylvania, 17403, United States
Willamette Valley Cancer Institute

Eugene, Oregon, 97401, United States
Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

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