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JOURNAL ONKOLOGIE – STUDIE

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Rekrutierend

NCT-Nummer:
NCT04895709

Studienbeginn:
Mai 2021

Letztes Update:
01.04.2024

Wirkstoff:
BMS-986340, BMS-936558-01, Docetaxel

Indikation (Clinical Trials):
Carcinoma, Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Melanoma, Carcinoma, Squamous Cell, Adenocarcinoma, Uterine Cervical Neoplasms, Breast Neoplasms, Carcinoma, Transitional Cell, Esophageal Neoplasms, Ovarian Neoplasms, Carcinoma, Renal Cell, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Bristol-Myers Squibb

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

BMS Study Connect Contact Center www.BMSStudyConnect.com
Kontakt:
Phone: 855-907-3286
E-Mail: Clinical.Trials@bms.com» Kontaktdaten anzeigen
First line of the email MUST contain NCT # and Site #.

Studienlocations
(3 von 47)

Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Martin Wermke, Site 0010
Phone: +493514587566» Ansprechpartner anzeigen
Memorial Sloan Kettering Nassau
10065 New York
United StatesAbgeschlossen» Google-Maps
Local Institution - 0035
5265601 Ramat Gan
IsraelZurückgezogen» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
20133 Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Filippo De Braud, Site 0024
Phone: 390223903066» Ansprechpartner anzeigen
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
00168 Roma
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Gennaro Daniele, Site 0040
Phone: +390630153446» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of

BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with

advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in

participants with advanced solid tumors.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker

analysis

- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and

at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion

biopsies are not acceptable.

- Eastern Cooperative Oncology Group Performance Status of 0 or 1

- Radiographically documented progressive disease on or after the most recent therapy

- Received standard-of-care therapies, (except for Part 1C, where participants with

prior docetaxel use for the advanced/metastatic setting will be excluded), including

an available programmed death (ligand)-1 inhibitor known to be effective in the tumor

type for which they are being evaluated

- Advanced or metastatic disease and have received, be refractory to, not be a candidate

for, or be intolerant of existing therapies known to provide clinical benefit for the

condition of the participant

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Primary central nervous system (CNS) malignancy

- Untreated CNS metastases

- Leptomeningeal metastases

- Concurrent malignancy requiring treatment or history of prior malignancy active within

2 years prior to the first dose of study treatment

- Active, known, or suspected autoimmune disease

- Condition requiring systemic treatment with either corticosteroids within 14 days or

other immunosuppressive medications within 30 days of the first dose of study

treatment

- Prior organ or tissue allograft

- Uncontrolled or significant cardiovascular disease

- Major surgery within 4 weeks of study drug administration

- History of or with active interstitial lung disease or pulmonary fibrosis

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Incidence of adverse events (AEs) (Time Frame - Up to 120 weeks)

2. Incidence of serious adverse events (SAEs) (Time Frame - Up to 120 weeks)

3. Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria (Time Frame - Up to 120 weeks)

4. Incidence of AEs leading to discontinuation (Time Frame - Up to 120 weeks)

5. Incidence of AEs leading to death (Time Frame - Up to 120 weeks)

Secondary outcome:

1. Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) (Time Frame - Up to 120 weeks)

2. PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) (Time Frame - Up to 120 weeks)

3. PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU)) (Time Frame - Up to 120 weeks)

4. PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) (Time Frame - Up to 120 weeks)

5. PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) (Time Frame - Up to 120 weeks)

6. PK parameters of BMS-986340 administered in combination with docetaxel: Cmax (Time Frame - Up to 120 weeks)

7. PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) (Time Frame - Up to 120 weeks)

8. PK parameters of BMS-986340 administered in combination with docetaxel: Tmax (Time Frame - Up to 120 weeks)

9. PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) (Time Frame - Up to 120 weeks)

10. PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU) (Time Frame - Up to 120 weeks)

11. PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau) (Time Frame - Up to 120 weeks)

12. PK parameters of BMS-986340 administered in combination with docetaxel: Ctau (Time Frame - Up to 120 weeks)

13. Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy (Time Frame - Up to 120 weeks)

14. Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab (Time Frame - Up to 120 weeks)

15. Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel (Time Frame - Up to 120 weeks)

16. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator (Time Frame - At 6 months, 12 months)

17. Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator (Time Frame - At 6 months, 12 months)

18. Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator (Time Frame - At 6 months, 12 months)

19. Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator (Time Frame - At 6 months, 12 months)

Studien-Arme

  • Experimental: Part 1A: BMS-986340 Dose Escalation
  • Experimental: Part 2A: BMS-986340 Dose Expansion
  • Experimental: Part 1B: BMS-986340 + Nivolumab Dose Escalation
  • Experimental: Part 2B: BMS-986340 + Nivolumab Dose Expansion
  • Experimental: Part 1C: BMS-986340 + Docetaxel Dose Escalation

Geprüfte Regime

  • BMS-986340:
    Specified dose on specified days
  • BMS-936558-01 (Nivolumab):
    Specified dose on specified days
  • Docetaxel:
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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