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

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 Primary Objectives • 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). Secondary Objectives • 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. • 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). • 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). • 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. • To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK). • To assess quality of life in the treated population using the Functional Assessment of Cancer Therapy – Cervical Cancer