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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04895709




Registration number
NCT04895709
Ethics application status
Date submitted
19/05/2021
Date registered
20/05/2021
Date last updated
6/05/2024

Titles & IDs
Public title
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Scientific title
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
2021-001188-26
Secondary ID [2] 0 0
CA052-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer 0 0
Gastric/Gastroesophageal Junction Adenocarcinoma 0 0
Microsatellite Stable Colorectal Cancer 0 0
Non-Small-Cell Lung Cancer 0 0
Squamous Cell Carcinoma of Head and Neck 0 0
Carcinoma, Renal Cell 0 0
Urothelial Carcinoma 0 0
Pancreatic Adenocarcinoma 0 0
Melanoma 0 0
Ovarian Neoplasms 0 0
Triple Negative Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)
Cancer 0 0 0 0
Bladder - transitional cell cancer
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Oesophageal (gullet)
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986340
Treatment: Drugs - BMS-936558-01
Treatment: Drugs - Docetaxel

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 -


Treatment: Drugs: BMS-986340
Specified dose on specified days

Treatment: Drugs: BMS-936558-01
Specified dose on specified days

Treatment: Drugs: Docetaxel
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
Up to 120 weeks
Primary outcome [2] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 120 weeks
Primary outcome [3] 0 0
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Timepoint [3] 0 0
Up to 120 weeks
Primary outcome [4] 0 0
Incidence of AEs leading to discontinuation
Timepoint [4] 0 0
Up to 120 weeks
Primary outcome [5] 0 0
Incidence of AEs leading to death
Timepoint [5] 0 0
Up to 120 weeks
Secondary outcome [1] 0 0
Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)
Timepoint [1] 0 0
Up to 120 weeks
Secondary outcome [2] 0 0
PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)
Timepoint [2] 0 0
Up to 120 weeks
Secondary outcome [3] 0 0
PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))
Timepoint [3] 0 0
Up to 120 weeks
Secondary outcome [4] 0 0
PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)
Timepoint [4] 0 0
Up to 120 weeks
Secondary outcome [5] 0 0
PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)
Timepoint [5] 0 0
Up to 120 weeks
Secondary outcome [6] 0 0
PK parameters of BMS-986340 administered in combination with docetaxel: Cmax
Timepoint [6] 0 0
Up to 120 weeks
Secondary outcome [7] 0 0
PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)
Timepoint [7] 0 0
Up to 120 weeks
Secondary outcome [8] 0 0
PK parameters of BMS-986340 administered in combination with docetaxel: Tmax
Timepoint [8] 0 0
Up to 120 weeks
Secondary outcome [9] 0 0
PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Timepoint [9] 0 0
Up to 120 weeks
Secondary outcome [10] 0 0
PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU)
Timepoint [10] 0 0
Up to 120 weeks
Secondary outcome [11] 0 0
PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)
Timepoint [11] 0 0
Up to 120 weeks
Secondary outcome [12] 0 0
PK parameters of BMS-986340 administered in combination with docetaxel: Ctau
Timepoint [12] 0 0
Up to 120 weeks
Secondary outcome [13] 0 0
Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy
Timepoint [13] 0 0
Up to 120 weeks
Secondary outcome [14] 0 0
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab
Timepoint [14] 0 0
Up to 120 weeks
Secondary outcome [15] 0 0
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel
Timepoint [15] 0 0
Up to 120 weeks
Secondary outcome [16] 0 0
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Timepoint [16] 0 0
At 6 months, 12 months
Secondary outcome [17] 0 0
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Timepoint [17] 0 0
At 6 months, 12 months
Secondary outcome [18] 0 0
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Timepoint [18] 0 0
At 6 months, 12 months
Secondary outcome [19] 0 0
Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Timepoint [19] 0 0
At 6 months, 12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/09/2026
Actual
Sample size
Target
665
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [5] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [6] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
3065 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Canada
State/province [12] 0 0
Ottawa
Country [13] 0 0
Germany
State/province [13] 0 0
Dresden
Country [14] 0 0
Germany
State/province [14] 0 0
Essen
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Ulm
Country [17] 0 0
Germany
State/province [17] 0 0
Wuerzburg
Country [18] 0 0
Israel
State/province [18] 0 0
HaMerkaz
Country [19] 0 0
Israel
State/province [19] 0 0
HaTsafon
Country [20] 0 0
Israel
State/province [20] 0 0
Tell Abib
Country [21] 0 0
Italy
State/province [21] 0 0
Milano
Country [22] 0 0
Italy
State/province [22] 0 0
Torino
Country [23] 0 0
Italy
State/province [23] 0 0
Milan
Country [24] 0 0
Italy
State/province [24] 0 0
Napoli
Country [25] 0 0
Italy
State/province [25] 0 0
Roma
Country [26] 0 0
Italy
State/province [26] 0 0
Siena
Country [27] 0 0
Japan
State/province [27] 0 0
Chiba
Country [28] 0 0
Spain
State/province [28] 0 0
Andalucía
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona [Barcelona]
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid, Comunidad De
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Pamplona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04895709
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04895709