TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma (TICIMEL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03293784|
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Combination Product: Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab Combination Product: Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab||Phase 1|
The study will be conducted in 2 consecutive parts:
- Part 1 with 2 parallel cohorts (Nivolumab+Ipilimumab administered in combination with anti-TNF-α Certolizumab (Cohort 1) and Nivolumab+Ipilimumab administered in combination with anti-TNF-α Infliximab (Cohort 2)). 6 patients will be included in each cohort.
- Part 2 (expansion phase) will then be scheduled after the most promising combination has been confirmed; the choice of the combination will be based on safety, efficacy, and PD data observed in both cohorts during the Part 1 of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma - A Phase Ib Clinical Study|
|Actual Study Start Date :||October 16, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||October 2022|
Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab
Combination Product: Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab
Induction phase: Nivolumab (1mg/kg) and Ipilimumab (3 mg/kg) injected at Week 0, 3, 6, and 9 with Certolizumab injected at the dose of 400mg at weeks 0, 3, and 6, and at the dose of 200mg at week 9.
Maintenance phase: Nivolumab (3 mg/kg) alone injected from week 12 and then every 2 weeks with Certolizumab (200 mg) injected from week 12 and then every 2 weeks.
Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab
Combination Product: Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab
Induction phase: Nivolumab (1mg/kg) and Ipilimumab 3 mg/kg injected at Week 0, 3, 6, and 9 with Infliximab (5mg/kg) injected at weeks 0, 3 and 6.
Maintenance phase: Nivolumab (3 mg/kg) alone injected from week 12 and then every 2 weeks with Infliximab (5mg/kg) injected from week 14 and then every 8 weeks.
- Dose Limiting Toxicities (DLT) incidence. [ Time Frame: 12 weeks per patient ]For each patient, DLT incidence will be evaluated during the Part 1 of the study: 12 weeks after the initial dose of study drug.
- Safety and tolerability according to the classification of the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) Version 4.03. [ Time Frame: 15 months per patient ]The assessment of safety and tolerability will be based on the incidence of Adverse Events (AEs), Serious Adverse Events, AEs leading to discontinuation, and death. In addition, clinical laboratory test abnormalities will be examined. Tolerability will be evaluated by collecting dose interruptions and dose delays.
- Progression Free Survival [ Time Frame: 24 months per patient ]Progression Free Survival (PFS) is defined as the time from inclusion until progression or deaths; patients alive at last follow-up news are censored at this date.
- Objective Response Rate [ Time Frame: 24 months per patient ]Objective Response Rate (ORR) is defined as the number of patients with Best Overall Response divided by the number of included patients in each cohort.
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): NCT03293784
|Contact: Nicolas MEYER||5 61 15 60 34 ext +email@example.com|
|Institut Claudius Regaud IUCT-ONCOPOLE||Recruiting|
|Toulouse, France, 31059|
|Contact: Nicolas MEYER, MD PHD 5 31 15 51 61 ext 33 Meyer.Nicolas@iuct-oncopole.fr|
|Principal Investigator:||Nicolas MEYER||Institut Claudius Regaud|