A study to evaluate the safety and tolerability of BMS-986408 alone and in combination with Nivolumab or Nivolumab and Ipilimumab in participants with advanced solid tumors
Résumé de l'étude
The primary objective of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with Nivolumab or Nivolumab and Ipilimumab, to determine the maximum tolerated dose (MTD). Additionally, the recommended phase 2 dose (RP2D) will be determined, optimizing the pharmacokinetic/pharmacodynamic (PK/PD) ratio of BMS-986408.
(BASEC)
Intervention étudiée
Experimental: Part 1: BMS-986408 Monotherapy: Drug: BMS-986408 ➔ Fixed dose on fixed days
Experimental: Part 2: BMS-986408 in combination with Nivolumab: Drug: BMS-986408 ➔ Fixed dose on fixed days Biological: Nivolumab ➔ Fixed dose on fixed days Other names: - Opdivo - BMS-936558
Experimental: Part 2: BMS-986408 in combination with Nivolumab and Ipilimumab Drug: BMS-986408 Fixed dose on fixed days Biological: Nivolumab Fixed dose on fixed days Other names: Opdivo BMS-936558 Biological: Ipilimumab Fixed dose on specific days Other names: - Yervoy - BMS-734016
(BASEC)
Maladie en cours d'investigation
Advanced solid tumors
(BASEC)
Inclusion criteria: • Participants with a histologically or cytologically confirmed, advanced, inoperable/metastatic solid malignant tumor of any histology that is measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 • Participants who have received an existing therapy known to provide clinical benefit for the participant's disease, have been refractory to it, are not eligible for it, or cannot tolerate it • Participants with melanoma must demonstrate mutation status for the B-Raf proto-oncogene (BRAF) and the neuroblastoma RAS viral oncogene homolog (NRAS) • Participants must have experienced radiologically documented disease progression at or after the last therapy. (BASEC)
Critères d'exclusion
Exclusion criteria: • An active, known or suspected autoimmune disease • Conditions requiring systemic treatment with corticosteroids within 14 days or other immunosuppressive medications within 30 days prior to the first dose of study treatment • Current or recently occurring gastrointestinal diseases or gastrointestinal surgeries that could affect the absorption of the study drug • Untreated metastases of the central nervous system (CNS) or leptomeningeal metastases Other inclusion/exclusion criteria as specified in the protocol. (BASEC)
Lieu de l’étude
Bâle, Genève, St-Gall
(BASEC)
Sponsor
Sponsor: Celgene Corporation Princeton, NJ, USA Sponsor`s representative: Dr. Carmen Lilla Bristol Myers Squibb SA, Steinhausen, Switzerland
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. Markus Jörger
+41 71 494 11 11
markus.joerger@clutterkssg.chCantonal Hospital St.Gallen, Rorschacherstrasse 95, st.Gallen, Sankt Gallen, Switzerland, 9007
(BASEC)
Informations générales
Bristol-Myers Squibb
(ICTRP)
Informations scientifiques
Bristol-Myers Squibb
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date d'approbation du comité d'éthique
10.05.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05407675 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
CA099-003: Eine Phase-1/2-Studie zu BMS-986408 allein und in Kombination mit Nivolumab oder mit Nivolumab und Ipilimumab bei Teil-nehmern mit fortgeschrittenen soliden Tumoren (BASEC)
Titre académique
A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors (ICTRP)
Titre public
A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors (ICTRP)
Maladie en cours d'investigation
Advanced Solid Tumors (ICTRP)
Intervention étudiée
Drug: BMS-986408;Biological: Nivolumab;Biological: Ipilimumab;Biological: Platinum-doublet chemotherapy;Drug: Rabeprazole (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Participants with a histologically or cytologically confirmed, advanced,
unresectable/metastatic, solid malignancy of any histology measurable by Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Participants who have received, been refractory to, ineligible for, or intolerant of
existing therapy(ies) known to provide clinical benefit for the condition of the
participant
- Participants with melanoma should have documentation of mutation status for B-type
Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
- Participants must have experienced radiographically documented progressive disease
on or after the most recent therapy
Exclusion Criteria:
- An active, known or suspected autoimmune disease
- Conditions requiring systemic treatment with either corticosteroids within 14 days
or other immunosuppressive medications within 30 days of the first dose of study
treatment
- Current or recent gastrointestinal disease or gastrointestinal surgery that could
impact the absorption of study drug
- Untreated central nervous system (CNS) metastases or leptomeningeal metastasis
Other protocol-defined inclusion/exclusion criteria apply (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Number of participants with Dose-Limiting Toxicities (DLTs);Number of participants with Adverse Events (AEs);Number of deaths (ICTRP)
Maximum concentration (Cmax);Time of maximum observed concentration (Tmax);Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T));Objective Response Rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;Duration of Response (DOR) assessed by RECIST v1.1 (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Bristol-Myers Squibb, Bristol-Myers Squibb (ICTRP)
ID secondaires
CA099-003 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05407675 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible