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

Summary

Objectives

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.