AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma

NCT04607200 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: C-550-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Angiosarcoma

Outcome Measures

Primary Outcomes (1)

• Response rate of single-agent AGEN2034 and combination AGEN2034 + AGEN1884

  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

  48 months

Study Arms (2)

Monotherapy

EXPERIMENTAL

AGEN2034 - dose of 3 mg/kg IV every 2 weeks for up to 24 months

Drug: AGEN2034

Combination Therapy

EXPERIMENTAL

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

Drug: AGEN2034; Drug: AGEN1884

Interventions

AGEN2034 DRUG

Anti-PD-1 Monoclonal Antibody

Also known as: Anti-PD-1

Combination Therapy; Monotherapy

AGEN1884 DRUG

Anti-CTLA-4 Monoclonal Antibody

Also known as: Anti-CTLA-4

Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed AS not amenable to curative intent surgery
• Prior treatment history for AS
• Cohort 1 and Cohort 3
• Patients who previously received and progressed after at least 1 prior therapy for AS.
• Checkpoint inhibitor (PD-1/PD-L1/CTLA-4) naïve
• Cohort 2
• Patients who previously received and progressed on or after at least 1 prior therapy for AS
• Prior treatment must include PD-1 or PD-L1 inhibitor such as nivolumab, pembrolizumab, atezolizumab, durvalumab, AGEN2034, or other, given either as the most recent treatment or earlier. Note: Confirmation of PD is required after treatment with prior checkpoint inhibitors
• CTLA-4 inhibitor naïve
• ≥ 18 years of age.
• At least one lesion measurable, either radiologically (computed tomography \[CT\], magnetic resonance imaging \[MRI\]) and/or using color photography with a ruler, as per RECIST v1.1
• Have a life expectancy of ≥ 3 months and an Eastern Cooperative Oncology Group Performance Status of 0 to 1
• Resolution of all acute AEs resulting from prior cancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 Grade ≤ 1
• Have adequate organ function as indicated by the following laboratory values:
• Adequate hematological function defined by absolute neutrophil count \> 1.5 × 10\^9/L, platelet count \> 75 × 10\^9/L, and hemoglobin \> 8 g/dL (without transfusions, within

You may not qualify if:

• Is currently participating and receiving study therapy or has participated in a different study of an investigational agent and received study therapy or used an investigation device within 3 weeks of the first dose of treatment
• Has an inadequate washout period prior to first dose of study drug defined as:
• \< 3 weeks from last dose of prior systemic cytotoxic chemotherapy or biological therapy
• \< 3 weeks from last radiation therapy
• \< 4 weeks from major surgery
• Known severe (Grade ≥ 3) hypersensitivity reactions to fully human mAbs, antibody, or severe reaction to immuno-oncology agents, such as colitis or pneumonitis requiring treatment with steroids
• Has received systemic corticosteroid therapy ≤ 7 days prior to the first dose of study treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on study for management of immune-related AEs, and/or a premedication for intravenous (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 7.5 mg or equivalent hydrocortisone dose are examples of permitted replacement therapy
• Known central nervous system 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, high-dose steroids must be discontinued ≥ 7 days prior to first dose of study drug but may be continued if ≤ 5 mg/day (prednisone)
• Has active or history of autoimmune disease requiring immunosuppressive systemic treatment (e.g. modifying agents, corticosteroids or immunosuppressive drugs) within previous 2 years Note: Thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is not considered a form of immunosuppressive systemic treatment.
• Note: Patients with Type 1 diabetes, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible
• Has had an allogeneic tissue/solid organ transplant
• Has or had interstitial lung disease or has had a history of pneumonitis anaphylaxis, or uncontrolled asthma that has required oral or IV corticosteroids
• Active infection requiring IV systemic therapy
• Known history of HIV type 1 or 2 antibodies

Sponsors & Collaborators

• Agenus Inc.: lead

MeSH Terms

Conditions

Hemangiosarcoma

Interventions

balstilimab; spartalizumab; Ipilimumab

Condition Hierarchy (Ancestors)

Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Agenus Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 29, 2020
• Study Start: February 1, 2021
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12