Condition or disease | Intervention/treatment | Phase |
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Retroperitoneal Sarcoma Resectable Sarcoma | Drug: Doxorubicin Drug: Ifosfamide Drug: INCMGA00012 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model 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 |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Phase II Study of Neoadjuvant Chemotherapy Plus Retifanlimab (INCMGA00012) in Patients With Selected Retroperitoneal Sarcomas |
Estimated Study Start Date : | February 1, 2022 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | September 2024 |
Arm | Intervention/treatment |
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Standard Arm A: treatment by neoadjuvant chemotherapy
Treatment by doxorubicin and ifosfamide followed by surgery
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Drug: Doxorubicin
Doxorubicin will administered by intravenous infusion on day 1 every 3 weeks (75 mg/m²) up to 4 cycles
Drug: Ifosfamide Ifosfamide will be administered by intravenous infusion over 3 days every 3 weeks (9 g/m²) up to 4 cycles
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Experimental: Experimental Arm B: treatement by neoadjuvant chemotherapy and retifanlimab
Treatment by doxorubicin, ifosfamide and retifanlimab followed by surgery
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Drug: Doxorubicin
Doxorubicin will administered by intravenous infusion on day 1 every 3 weeks (75 mg/m²) up to 4 cycles
Drug: Ifosfamide Ifosfamide will be administered by intravenous infusion over 3 days every 3 weeks (9 g/m²) up to 4 cycles
Drug: INCMGA00012 Retifanlimab will be administered by intravenous infusion on day 1every 3 weeks (375 mg) up to 4 cycles
Other Name: Retifanlimab
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
Uncontrolled or significant renal disease including, but not limited to, any of the following:
Has an active autoimmune disease
Contact: Antoine ITALIANO, MD, PhD | +33556333333 | a.italiano@bordeaux.unicancer.fr | |
Contact: Simone MATHOULIN-PELISSIER, MD, PhD | s.mathoulin@bordeaux.unicancer.fr |
France | |
Institut Bergonié | |
Bordeaux, France, 33076 | |
Contact: Antoine ITALIANO, MD, PhD a.italiano@bordeaux.unicancer.fr | |
Centre Léon Bérard | |
Lyon, France | |
Contact: Mehdi BRAHMI, MD mehdi.brahmi@lyon.unicancer.fr | |
Institut Curie | |
Paris, France | |
Contact: Sarah WATSON, MD sarah.watson@curie.fr | |
Institut Gustave Roussy | |
Villejuif, France, 94805 | |
Contact: Olivier MIR, MD olivier.mir@gutaveroussy.fr |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 13, 2021 | ||||||||
First Posted Date ICMJE | July 20, 2021 | ||||||||
Last Update Posted Date | December 7, 2021 | ||||||||
Estimated Study Start Date ICMJE | February 1, 2022 | ||||||||
Estimated Primary Completion Date | March 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Neoadjuvant Chemotherapy and Retifanlimab in Patients With Selected Retroperitoneal Sarcomas (TORNADO) | ||||||||
Official Title ICMJE | Randomized Phase II Study of Neoadjuvant Chemotherapy Plus Retifanlimab (INCMGA00012) in Patients With Selected Retroperitoneal Sarcomas | ||||||||
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. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model 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 Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
66 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 2024 | ||||||||
Estimated Primary Completion Date | March 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04968106 | ||||||||
Other Study ID Numbers ICMJE | IB 2021-01 2021-001085-37 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Institut Bergonié | ||||||||
Study Sponsor ICMJE | Institut Bergonié | ||||||||
Collaborators ICMJE | Incyte Biosciences International Sàrl | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Institut Bergonié | ||||||||
Verification Date | December 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |