Randomized Phase II Study of Neoadjuvant Chemotherapy Plus Retifanlimab (INCMGA00012) in Patients With Selected Sarcomas
Overview
- Phase
- Phase 2
- Intervention
- INCMGA00012
- Conditions
- Resectable Sarcoma
- Sponsor
- Institut Bergonié
- Enrollment
- 66
- Locations
- 7
- Primary Endpoint
- Assessment of the antitumor activity of retifanlimab when prescribed in association with neoadjuvant chemotherapy (doxorubicin+ifosfamide)
- Status
- Active, Not Recruiting
- Last Updated
- 11 days ago
Overview
Brief Summary
Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of retifanlimab (INCMGA00012) in association with neoadjuvant chemotherapy
Detailed Description
This is a multicenter, prospective, open-labeled, 2-arm, non-comparative randomized (1:1) phase II trial. Patients will be randomized between arm A (neodjuvant chemotherapy by doxorubicin + ifosfamide) and arm B (neodjuvant chemotherapy by doxorubicin + ifosfamide and retifanlimab) with one patient randomized in arm A for one patient randomized in arm B.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with grade 2 or grade 3 soft-tissue sarcoma (limb, trunk wall, retroperitoneum) histologically confirmed and reviewed by the RRePS Network
- •For TLS status determination: available archived FFPE tumor tissue sample.
- •Presence of mature tertiary lymphoid structures. Except if presence of TLS have been already confirmed by Biopathological platform at Bergonié Institute, presence of TLS should be confirmed by central review based on FFPE tumor tissue sample (archived or newly obtained by biopsy for research purpose).
- •Non-metastatic and resectable disease,
- •At least one lesion that can be biopsied for research purpose,
- •No prior treatment for the disease under study,
- •Age ≥ 18 years,
- •Life expectancy \> 3 months,
- •Patients must have measurable disease defined as per RECIST v1.1
- •Adequate hematological, renal, metabolic and hepatic function
Exclusion Criteria
- •Previous treatment for retroperitoneal sarcoma including surgery, chemotherapy or radiotherapy
- •Previous treatments with doxorubicin, daunorubicin, epirubicin, idarubicin and/or other anthracyclines or anthracenediones at the maximum cumulative dose,
- •Known hypersensitivity to any involved study drug or any of its formulation components,
- •Has an active or ongoing infection requiring systemic therapy,
- •Known central nervous system malignancy (CNS),
- •Women who are pregnant or breast feeding,
- •Has known active hepatitis B or hepatitis C,
- •Has a known history of Human Immunodeficiency Virus (HIV),
- •Previous enrolment in the present study,
- •Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
Arms & Interventions
Experimental Arm B: treatement by neoadjuvant chemotherapy and retifanlimab
Treatment by doxorubicin, ifosfamide and retifanlimab followed by surgery
Intervention: INCMGA00012
Standard Arm A: treatment by neoadjuvant chemotherapy
Treatment by doxorubicin and ifosfamide followed by surgery
Intervention: Doxorubicin
Experimental Arm B: treatement by neoadjuvant chemotherapy and retifanlimab
Treatment by doxorubicin, ifosfamide and retifanlimab followed by surgery
Intervention: Doxorubicin
Standard Arm A: treatment by neoadjuvant chemotherapy
Treatment by doxorubicin and ifosfamide followed by surgery
Intervention: Ifosfamide
Experimental Arm B: treatement by neoadjuvant chemotherapy and retifanlimab
Treatment by doxorubicin, ifosfamide and retifanlimab followed by surgery
Intervention: Ifosfamide
Outcomes
Primary Outcomes
Assessment of the antitumor activity of retifanlimab when prescribed in association with neoadjuvant chemotherapy (doxorubicin+ifosfamide)
Time Frame: 5 months after treatment onset
Antitumor activity will be assessed in terms of histological response based on surgical sample
Secondary Outcomes
- 1-year progression-free survival(1 year)
- 3-year progression-free survival(3 years)
- 1-year overall survival(1 year)
- 3-year overall survival(3 years)
- Safety profile independently for each arm: Common Terminology Criteria for Adverse event version 5(Throughout the treatment period, an expected average of 6 months)