ImmunoModulation by the Combination of Ipilimumab and Nivolumab Neoadjuvant to Surgery In Advanced or Recurrent Head and Neck Carcinoma (IMCISION)
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|ClinicalTrials.gov Identifier: NCT03003637|
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : February 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Immunotherapy Head and Neck Neoplasms||Drug: Nivolumab Drug: Ipilimumab||Phase 1 Phase 2|
The phase Ib is designed as 3 + 3, with primary objective feasibility and toxicity.
Of Note: endpoints must be reached in all 6 patients of cohort 1 and 2, before start of the next cohort.
The phase II is designed as a single arm design with primary endpoint efficacy.
In phase Ib, two cohorts will be used (cohort 1: nivolumab only and cohort 2: nivolumab and ipilimumab neoadjuvant to surgery) to define which neoadjuvant immunotherapy regimen will be taken towards the expansion cohort 3.
Thirty-two patients will be treated with nivolumab (240 mg flat dose, week 1 and week 3, twice in total) as a single agent OR the combination of ipilimumab (1 mg/kg) + nivolumab (240mg flat dose) in week 1, and nivolumab 240mg flat dose in week 3, neoadjuvant to SOC (surgery with or without adjuvant (C)RT).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ImmunoModulation by the Combination of Ipilimumab and Nivolumab Neoadjuvant to Surgery In Advanced Or Recurrent Head and Neck Carcinoma. Subtitle: Hypoxia as a Determinant for the Effect of Nivolumab With or Without Ipilimumab on Intra-tumoral T Cell Capacity|
|Actual Study Start Date :||February 28, 2017|
|Actual Primary Completion Date :||October 12, 2019|
|Actual Study Completion Date :||February 12, 2021|
Experimental: Nivolumab with or without Ipilimumab
First dose scheme will be 2x nivolumab 240 mg flat dose, weeks 1 and 3. When feasible and safe, the next patients will be treated with the following dose scheme: the combination of 1x ipilimumab 1 mg/kg + nivolumab 240 mg flat dose in week 1 and nivolumab mono-therapy 240 mg flat dose in week 3
Nivolumab (240 mg flat dose, week 1 and week 3, twice in total) monotherapy, neoadjuvant to SOC (surgery with or without adjuvant (C)RT).
Other Name: Nivolumab (Opdivo) BMS-936558-01
Ipilimumab (1 mg/kg) only in week 1, in combination with nivolumab (240 mg flat dose, week 1 and week 3, twice in total), neoadjuvant to SOC (surgery with or without adjuvant (C)RT).
Other Name: Ipilimumab (Yervoy) BMS
- Phase Ib: the number of patients that will not endure a delay in surgery due to neoadjuvant immunotherapy related toxicity OR toxicity due to the treatment of immunotherapy related toxicity. [ Time Frame: 2.5 years ]
- Phase II: Tumor response to neoadjuvant IT in terms of tumor tissue pathological response at time of surgery compared to RECIST 1.1 (FDG-PET and perfusion and diffusion weighted MRI). [ Time Frame: 2.5 years ]
- Phase Ib/II: the potential impact of local tumor hypoxia on tumor T-cell abundance and capacity before and after neo-adjuvant immunotherapy, through HX4-PET-guided tumor biopsies from hypoxic and normoxic tumor regions. [ Time Frame: 2.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003637
|Amsterdam, Noord-Holland, Netherlands, 1066CX|
|Principal Investigator:||Lotje Zuur, MD, PhD||NKI-AvL|