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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Basel, Genf, St Gallen
(BASEC)
Sponsor
Sponsor: Celgene Corporation Princeton, NJ, USA Sponsor`s representative: Dr. Carmen Lilla Bristol Myers Squibb SA, Steinhausen, Switzerland
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
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)
Allgemeine Auskünfte
Bristol-Myers Squibb
(ICTRP)
Wissenschaftliche Auskünfte
Bristol-Myers Squibb
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
10.05.2023
(BASEC)
ICTRP Studien-ID
NCT05407675 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
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)
Untersuchte Krankheit(en)
Advanced Solid Tumors (ICTRP)
Untersuchte Intervention
Drug: BMS-986408;Biological: Nivolumab;Biological: Ipilimumab;Biological: Platinum-doublet chemotherapy;Drug: Rabeprazole (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Bristol-Myers Squibb, Bristol-Myers Squibb (ICTRP)
Sekundäre IDs
CA099-003 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05407675 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar