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A Study of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors

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ClinicalTrials.gov Identifier: NCT03792750
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine safety and effectiveness of experimental medication BMS-986205 in combination with Nivolumab in patients with cancers that are advanced or have spread.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: BMS-986205 Biological: Nivolumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : June 28, 2020
Estimated Study Completion Date : June 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Experimental Arm A
2 week BMS-986205 monotherapy lead in followed by BMS-986205 + Nivo combination therapy
Drug: BMS-986205
Specified Dose on Specified Day

Biological: Nivolumab
Specified Dose on Specified Day
Other Name: BMS-936558




Primary Outcome Measures :
  1. Incidence of Adverse Events (AE) [ Time Frame: Approximately 65 weeks ]
  2. Incidence of Serious Adverse Events (SAE) [ Time Frame: Approximately 65 weeks ]
  3. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 50 weeks ]
  4. Incidence of death [ Time Frame: Approximately 65 weeks ]
  5. Incidence of Laboratory abnormalities [ Time Frame: Approximately 65 weeks ]
  6. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 65 weeks ]
  7. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 65 weeks ]
  8. Apparent total body clearance (CLT/F) [ Time Frame: Approximately 65 weeks ]
  9. Apparent volume of distribution at steady-state (Vss/F) [ Time Frame: Approximately 65 weeks ]
  10. Accumulation index, calculated based on ratio of AUC(TAU) and Cmax at steady state to after the first dose (AI) [ Time Frame: Approximately 65 weeks ]
  11. Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 65 weeks ]
  12. Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Approximately 65 weeks ]
  13. 10.Percent urinary recovery over 24 hours corrected for molecular weight (%UR) [ Time Frame: Approximately 65 weeks ]

Secondary Outcome Measures :
  1. Incidence of anti-drug antibody (ADA) to Nivolumab [ Time Frame: Approximately 65 weeks ]
  2. Kynurenine serum levels [ Time Frame: Approximately 50 weeks ]
  3. Tryptophan serum levels [ Time Frame: Approximately 50 weeks ]
  4. Overall response rate (ORR) [ Time Frame: Approximately 50 weeks ]
  5. Best overall response (BOR) [ Time Frame: Approximately 50 weeks ]
  6. Duration of Response (DOR) [ Time Frame: Approximately 50 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have histologic or cytological confirmation of a solid tumor that is advanced with measureable disease per RECIST v1.1
  • Participants must have received, and then progressed or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting
  • Participants must have an ECOG performance status of less than or equal to 1
  • Participants must have at least 1 lesion with measurable disease as defined by RECIST Version 1.1

Exclusion Criteria:

  • Participants must not have suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease
  • Participants with prior exposure to anti PD-1 or anti-PDL1 therapy
  • Participants must not have a history of allergy to any of the study treatment components

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792750


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
China, Zhejiang
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03792750     History of Changes
Other Study ID Numbers: CA017-076
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Nivolumab
Antineoplastic Agents