AGEN2034 Alone or With AGEN1884 for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+67 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Agenus Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 with advanced cervical cancer that has worsened after first-line platinum-based chemotherapy. Participants must have a specific type of tumor, measurable disease, good organ function, and an ECOG performance status of 0 or 1. They should not be pregnant, agree to use two barrier methods of contraception if applicable, and provide a tumor tissue sample.

Inclusion Criteria

My cervical cancer returned after first-line platinum-based treatment.

My cancer can be measured on scans according to specific criteria.

I am using two reliable forms of birth control during the study.

+17 more

Exclusion Criteria

You have a history of severe allergic reactions to fully human monoclonal antibodies, a history of anaphylaxis, or uncontrolled asthma.

Has an inadequate washout period prior to first dose of study drug.

You have used illegal drugs or abused alcohol within the last year.

+17 more

Participant Groups

The RaPiDS Phase 2 trial tests AGEN2034 alone (monotherapy) or combined with AGEN1884 (combination therapy) in patients with second-line cervical cancer. It's randomized and blinded but doesn't compare the two arms directly; each arm's efficacy is measured against historical controls.

2Treatment groups

Experimental Treatment

Group I: AGEN2034 + PlaceboExperimental Treatment1 Intervention

AGEN2034 administered with placebo monotherapy: approximately 100 patients.

Group II: AGEN2034 + AGEN1884Experimental Treatment2 Interventions

AGEN2034 administered in combination with AGEN1884 (combination therapy): approximately 100 patients.