Phase II Trial of Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+ Anaplastic Large Cell Lymphoma, for Evaluation of Response in Patients With Progressive Disease (Cohort 1) or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse (Cohort 2) (NIVO-ALCL)
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|ClinicalTrials.gov Identifier: NCT03703050|
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Relapsing/Refractory ALK+ Anaplastic Large Cell Lymphoma||Drug: Nivolumab cohort 1 Drug: Nivolumab cohort 2||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, non-randomized, single arm phase II trial with 2 cohorts of ALK+ ALCL treated with nivolumab, according to patient status after previous treatment (patients in progression, into the Cohort 1; patients in CR, into the Cohort 2)|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+ Anaplastic Large Cell Lymphoma, for Evaluation of Response in Patients With Progressive Disease (Cohort 1) or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse (Cohort 2)|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2026|
Experimental: Cohort 1
Population: relapsed/refractory ALK+ ALCL with progressive disease after treatment (including chemotherapy and ALK inhibitor and/or brentuximab vedotin).
Drug: Nivolumab cohort 1
Induction: nivolumab 3 mg/kg (maximal unitary dose: 240 mg) iv Q2W until CR Evaluation of response as defined below, including biopsy in case of residual masses at Week 24 Maintenance: nivolumab 3 mg/kg (maximal unitary dose: 240 mg) Q4W Total duration of treatment (induction + maintenance) = 24 months
Experimental: Cohort 2
Population: patients with a relapsed/refractory ALCL, having achieved CR with a treatment including ALK-inhibitor or Brentuximab vedotin of at least 2 months and for whom HSCT is considered for their consolidation therapy. In this case, nivolumab would be considered as consolidative immunotherapy instead as HSCT.
Drug: Nivolumab cohort 2
Induction: nivolumab 3 mg/kg iv Q2W for 4 doses (Wk0, Wk2, Wk4 and Wk6) Maintenance: nivolumab 3 mg/kg Q4W, for 25 doses, starting at Week 8 (14 days after the last induction dose) Total duration of treatment (induction + maintenance) = 24 months
- Cohort 1 - Best objective response rate (Complete Response + Partial Response) [ Time Frame: within the first 24 weeks ]In case of PET-positive residual masses after 24 weeks of induction treatment, a resection/biopsy must be performed by week 24. A residual mass proven to be pathologically negative for disease after resection or limited biopsy is considered as CR after discussion with the Coordinating investigator.
- Cohort 2 - 3-year Progression Free Survival [ Time Frame: up to 3 years ]PFS is defined as the time since the inclusion in the trial to the first event among relapse and death (whatever the cause of death).
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): NCT03703050
|Contact: Laurence BRUGIERES, MD||0142114178 ext +email@example.com|
|Contact: Anne AUPERIN, MD||0142115499 ext +firstname.lastname@example.org|
|Villejuif, Val De Marne, France, 94805|
|Contact: Laurence BRUGIERES, MD 0142114178 ext +33 email@example.com|
|Study Chair:||Laurence BRUGIERES, MD||Gustave ROUSSY|