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Brief Title: BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

INTRODUCTION

  • Org Study ID: CA052-002
  • Secondary ID: N/A
  • NCT ID: NCT04895709
  • Sponsor: Bristol-Myers Squibb

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.

  • Overall Status
    Recruiting
  • Start Date
    May 27, 2021
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of adverse events (AEs)

Primary Outcome 1 - Timeframe: Up to 120 weeks

Primary Outcome 2 - Measure: Incidence of serious adverse events (SAEs)

Primary Outcome 2 - Timeframe: Up to 120 weeks

Primary Outcome 3 - Measure: Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

Primary Outcome 3 - Timeframe: Up to 120 weeks

Primary Outcome 4 - Measure: Incidence of AEs leading to discontinuation

Primary Outcome 4 - Timeframe: Up to 120 weeks

Primary Outcome 5 - Measure: Incidence of AEs leading to death

Primary Outcome 5 - Timeframe: Up to 120 weeks

CONDITION

  • Cervical Cancer
  • Gastric/Gastroesophageal Junction Adenocarcinoma
  • Microsatellite Stable Colorectal Cancer
  • Non-Small-Cell Lung Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Carcinoma
  • Renal Cell
  • Urothelial Carcinoma
  • Pancreatic Adenocarcinoma
  • Melanoma
  • Ovarian Neoplasms
  • Triple Negative Breast Neoplasms

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Bristol-Myers Squibb

Phone: 855-907-3286,

Email: Clinical.Trials@bms.com,

LOCATION

Facility Status Contact
Facility: John Theurer Cancer Center
Hackensack, New Jersey 07601
United States
Status: Recruiting Contact: Contact
Martin Gutierrez, Site 0007
551-996-5863

Facility: Columbia University Irving Medical Center
New York, New York 10032
United States
Status: Recruiting Contact: Contact
Shaheer Khan, Site 0006
646-942-4921

Facility: Memorial Sloan Kettering Nassau
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Margaret Callahan, Site 0002
186-049-0095

Facility: Providence Cancer Center Oncology and Hematology Care- Eastside
Portland, Oregon 97213
United States
Status: Recruiting Contact: Contact
Rom Leidner, Site 0001
503-215-5696

Facility: Local Institution - 0057
Blacktown, New South Wales 2148
Australia
Status: Recruiting Contact: Contact
Site 0057

Facility: Local Institution - 0054
Brisbane, Queensland 4102
Australia
Status: Recruiting Contact: Contact
Site 0054

Facility: Local Institution - 0053
Malvern, Victoria 3144
Australia
Status: Recruiting Contact: Contact
Site 0053

Facility: Local Institution - 0055
Melbourne, Victoria 3065
Australia
Status: Recruiting Contact: Contact
Site 0055

Facility: Local Institution - 0027
Edmonton, Alberta T6X 1E8
Canada
Status: Recruiting Contact: Contact
Site 0027

Facility: Local Institution - 0009
Toronto, Ontario M5G 2M9
Canada
Status: Recruiting Contact: Contact
Site 0009

Facility: Local Institution - 0015
Montreal, Quebec H2X 0A9
Canada
Status: Recruiting Contact: Contact
Site 0015

Facility: Local Institution - 0016
Ottawa, K1H 8L6
Canada
Status: Recruiting Contact: Contact
Site 0016

Facility: Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit
Dresden, 01307
Germany
Status: Recruiting Contact: Contact
Martin Wermke, Site 0010
+493514587566

Facility: Universitaetsklinikum Essen
Essen, 45147
Germany
Status: Recruiting Contact: Contact
Stefan Kasper-Virchow, Site 0018
0049201 7233449

Facility: Universitatsklinikum Frankfurt
Frankfurt, 60590
Germany
Status: Recruiting Contact: Contact
Martin Sebastian, Site 0020
+496963016217

Facility: Universitaetsklinikum Wuerzburg
Wuerzburg, 97078
Germany
Status: Recruiting Contact: Contact
Cyrus Sayehli, Site 0019
4993120140964

Facility: Local Institution - 0036
Petah Tikva, HaMerkaz 4941492
Israel
Status: Recruiting Contact: Contact
Site 0036

Facility: Local Institution - 0038
Ramat Gan, HaMerkaz 5265601
Israel
Status: Recruiting Contact: Contact
Site 0038

Facility: Local Institution - 0039
Haifa, HaTsafon 3109601
Israel
Status: Recruiting Contact: Contact
Site 0039

Facility: Local Institution - 0037
Tel Aviv, Tell Abīb 6423906
Israel
Status: Recruiting Contact: Contact
Site 0037

Facility: Humanitas
Rozzano, Milano 20089
Italy
Status: Recruiting Contact: Contact
Matteo Simonelli, Site 0023
+390282244559

Facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino 10060
Italy
Status: Recruiting Contact: Contact
Vanesa Gregorc, Site 0033
390119933250

Facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
Milan, 20133
Italy
Status: Recruiting Contact: Contact
Filippo De Braud, Site 0024
390223903066

Facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, 80131
Italy
Status: Recruiting Contact: Contact
Paolo Ascierto, Site 0034
390815903431

Facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168
Italy
Status: Recruiting Contact: Contact
Gennaro Daniele, Site 0040
+39 06 3015 3446

Facility: ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena, 53100
Italy
Status: Recruiting Contact: Contact
Michele Maio, Site 0025
390577586335

Facility: Local Institution - 0048
Málaga, Andalucía 29010
Spain
Status: Recruiting Contact: Contact
Site 0048

Facility: Local Institution - 0014
Badalona, Barcelona [Barcelona] 08916
Spain
Status: Recruiting Contact: Contact
Site 0014

Facility: Local Institution - 0049
Barcelona, Barcelona [Barcelona] 08035
Spain
Status: Recruiting Contact: Contact
Site 0049

Facility: Local Institution - 0047
Madrid, Madrid, Comunidad De 28041
Spain
Status: Recruiting Contact: Contact
Site 0047

Facility: Local Institution - 0013
Madrid, 28040
Spain
Status: Recruiting Contact: Contact
Site 0013

Facility: Local Institution - 0011
Madrid, 28050
Spain
Status: Recruiting Contact: Contact
Site 0011

Facility: Local Institution - 0012
Pamplona, 31008
Spain
Status: Recruiting Contact: Contact
Site 0012