AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma

Phase 2

Withdrawn

• Conditions: Angiosarcoma
• Interventions: Drug: AGEN2034; Drug: AGEN1884

• Registration Number: NCT04607200
• Lead Sponsor: Agenus Inc.

Brief Summary

This Phase 2, open-label study is designed to examine the efficacy and safety of single-agent AGEN2034 and combination AGEN2034 + AGEN1884 in patients with recurrent, inoperable or metastatic Angiosarcoma (AS).

Detailed Description

This Phase 2, open-label study is designed to examine the efficacy and safety of single-agent AGEN2034 and combination AGEN2034 + AGEN1884 in patients with recurrent, inoperable or metastatic AS.

Three cohorts will be enrolled into 2 Parts of the study as follows:

Part 1

* Cohort 1: Qualifying patients that are checkpoint inhibitor naïve will be enrolled into single-agent AGEN2034

* Cohort 2: Qualifying patients that are inhibitor (PD-1/L1) resistant will be enrolled into combination AGEN2034 + AGEN1884

Part 2

• Cohort 3: Qualifying patients that are checkpoint inhibitor naïve will be enrolled into combination AGEN2034 + AGEN1884. Part 2 will begin enrollment after enrollment in Part 1 is completed

The study will be conducted in 2 parts:

In Part 1, checkpoint inhibitor naïve patients will be treated with single-agent AGEN2034 (Cohort 1) and patients resistant to PD-1/PD-L1 (defined as prior progression on PD 1/PD-L1 treatment) will be treated with combination of AGEN2034+AGEN1884 (Cohort 2). Patients from Cohort 1 who experience PD may be considered (as PD-1 resistant) for transition to Cohort 2.

In Part 2, the study will enroll checkpoint inhibitor naïve patients for treatment with combination AGEN2034+AGEN1884 (Cohort 3). Part 2 will begin enrollment after enrollment in Part 1 is completed.

All patients will receive study treatment for up to 2 years until confirmed disease progression, unacceptable toxicity, or until the patient wishes to withdraw consent for any reason. Patients will be followed for safety at 30 and 90 days, and for survival every 2 months for at least 12 months from their last dose of study treatment. Each treatment cycle will be 6 weeks.

An IRC will be established to adjudicate tumor response based on imaging studies, photography, and clinical response. The primary endpoints will be based on the IRC assessment of response per RECIST v1.1.

Study Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-29
• Study Start: 2021-02
• Primary Completion: 2021-09-13
• Study Completion: 2021-09-13
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monotherapy	AGEN2034	AGEN2034 - dose of 3 mg/kg IV every 2 weeks for up to 24 months
Combination Therapy	AGEN2034	AGEN2034 - dose of 3 mg/kg IV every 2 weeks + AGEN1884 - dose of 1 mg/kg IV every 6 weeks (following AGEN2034 infusion), for up to 24 months
Combination Therapy	AGEN1884	AGEN2034 - dose of 3 mg/kg IV every 2 weeks + AGEN1884 - dose of 1 mg/kg IV every 6 weeks (following AGEN2034 infusion), for up to 24 months

Primary Outcome Measures

Name	Time	Method
Response rate of single-agent AGEN2034 and combination AGEN2034 + AGEN1884	48 months	To evaluate the response rate of single-agent AGEN2034 and combination AGEN2034 + AGEN1884 per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in patients with recurrent angiosarcoma