Loading clinical trials...

COMPLETEDPHASE1

TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma

TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma - A Phase Ib Clinical Study

NCT03293784•Institut Claudius Regaud

Summary

This is a Phase 1b, open-label study of immune checkpoints inhibitors Nivolumab+Ipilimumab administered in combination with the anti-TNF-α either Infliximab or Certolizumab, in patients with advanced melanoma.

Detailed Description

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 2009), including mucosal melanoma, without evidence of active intra-cranial disease.
•2. Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
•3. Measurable disease per RECIST 1.1
•4. Age ≥18 years and ≤70 years at the time of study entry.
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
•6. Life expectancy of at least 3 months.
•7. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures and to comply with the study protocol.
•8. Screening laboratory values must meet the following criteria and should be obtained prior to commencement of treatment:
•White blood count (WBC) ≥ 2000/μL Neutrophils ≥ 1500/μL Platelets ≥ 100 x103/μL Hemoglobin \> 9.0 g/dL
•Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below):
+25 more criteria

Exclusion Criteria

•1. Patient pregnant, or breast-feeding.
•2. Uveal melanoma.

Locations (1)

Institut Claudius Regaud IUCT-ONCOPOLE

Toulouse, France

Key Dates

Start Date

October 16, 2017

Primary Completion Date

December 6, 2019

Completion Date

August 10, 2023

Last Updated

August 14, 2023

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab

COMBINATION_PRODUCT

Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab

COMBINATION_PRODUCT

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

RECRUITINGPHASE1

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial

Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma