A Phase II of Nivolumab Plus Ipilimumab in Non-resectable Sarcoma and Endometrial Carcinoma
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|ClinicalTrials.gov Identifier: NCT02982486|
Recruitment Status : Not yet recruiting
First Posted : December 5, 2016
Last Update Posted : November 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma Bone Sarcoma Chondrosarcoma Gastrointestinal Stromal Sarcoma Ewing's Tumor Metastatic Ewing's Tumor Recurrent Osteosarcoma Desmoplastic Small Round Cell Tumor||Drug: Ipilimumab Drug: Nivolumab||Phase 2|
The expected duration of this study is 36 months (18 months accrual period and 18 month follow up period). Enrollment into the screening or treatment phase of the study will be stopped when the actual subject numbers have been achieved.
This single arm single institution, open label, prospective, phase II trial will evaluate the efficacy and safety of Nivolumab 240 mg IV every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks in patients with nonresectable/metastatic sarcoma or endometrial carcinoma with somatic deficient MMR as a selection tool.patients. Number of patients in the study will reflect the reconciliation between statistical requirements and incidence.
Treatment will continue until disease progression, development of unacceptable toxicity, noncompliance or withdrawal of consent by the patient or investigator decision.
All screening requirements must be completed within 28 days of the visit (except for Patients will be examined on cycle 1 day-1 and every 2 weeks, including complete blood count (CBC) and chemistry, until disease progression. CT/MRI imaging (contrast) will be performed every 6 weeks for response evaluation for the first 48 weeks and every 12 weeks thereafter. Clinical benefit as well as individual categories of response (complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) will be determined using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST). Response duration endpoints, including median PFS, PFS at 12 and 24 weeks and OS will be assessed using the Kaplan-Meier method. Toxicity (AEs) will be recorded using the NCI- Common Toxicity Criteria for Adverse Effects v 4.03 (NCI-CTCAE). Screening procedures will include immunostaining for MLH1, MSH2, MSH6 and PMS2 all performed on formalin fixed paraffin embedded (FFPE) tissue sections. In addition tumor DNA, extracted from FFPE tissue (after choosing optimal area by a Pathologist), will be submitted to FoundationOne for a later exploratory analysis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Single Arm Study Assessing Efficacy & Safety of Nivolumab Plus Ipilimumab in Nonresectable/Metastatic Sarcoma and Endometrial Carcinoma Patients With Somatic Deficient MMR as a Selection Tool|
|Estimated Study Start Date :||December 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Nivolumab and ipilimumab
Nivolumab 240 mg IV every 2 weeks plus Ipilimumab 1 mg/m2 IV every 6 weeks
Ipilimumab 1 mg/kg every 6 weeks
Other Name: anti CTLA4
Ninolumab 240 mg IV every 2 weeks
Other Name: Anti PD-1
- Response to therapy as evaluated by RECIST 1.1 [ Time Frame: 36 months ]complete and partial response
- Median Progression-free survival (PFS) [ Time Frame: 36 months ]PFS will be computed from the date of start of treatment to the first documented date of progression or the date of death, due to any cause assessed by investigator.
- Progression-free survival (PFS) assessed at 12 weeks [ Time Frame: 12 weeks ]PFS will be computed from the date of start of treatment to week 12 as assessed by investigator.
- Progression-free survival (PFS) assessed at 24 weeks [ Time Frame: 24 weeks ]PFS will be computed from the date of start of treatment to week 24 as assessed by investigator
- overall survival [ Time Frame: 36 months ]will be computed from the date of start of treatment to the date of death, due to any cause. Patients alive or lost for follow-up at the time of the analysis will be censored at the date of last follow-up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982486
|Contact: Daniela Katz, MDemail@example.com|
|Contact: Sharona Ben Amifirstname.lastname@example.org|
|Principal Investigator:||Daniela Katz, M.D||Assaf-Harofeh Medical Center|