NCT03792750 is a Phase 1, PHASE2 clinical trial of BMS-986205 in Advanced Cancer, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT03792750?

NCT03792750 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT03792750?

Interventions in NCT03792750: BMS-986205, Nivolumab.

What condition does NCT03792750 study?

NCT03792750 studies Advanced Cancer.

Is NCT03792750 still recruiting?

NCT03792750 is currently completed. Last updated 28 February 2022.

Are results published for NCT03792750?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-02-28 · How we verify

NCT03792750

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Results posted Last updated 28 February 2022

What this trial tests

Phase 1, PHASE2 trial testing BMS-986205 in Advanced Cancer in 12 participants. Completed in 18 December 2020.

Timeline

31 December 2018

Primary endpoint
18 December 2020

18 December 2020

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	31 December 2018
Primary completion	18 December 2020
Estimated completion	18 December 2020
Sites	1 location across China

Drugs / interventions tested

BMS-986205 — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Advanced Cancer — all drugs for Advanced Cancer →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Participants Experiencing Adverse Events (AE) Primary · From first dose to 100 days after last dose of study therapy (up to approximately 2 years)

The number of participants experiencing adverse events (AEs) to assess the safety and tolerability of BMS-986205. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	11

The Number of Participants Experiencing Serious Adverse Events (SAE) Primary · From first dose to 100 days after last dose of study therapy (up to approximately 2 years)

The number of participants experiencing serious adverse events (SAEs) to assess the safety and tolerability of BMS-986205 Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	3

The Number of Participants Experience Adverse Events (AE) Leading to Discontinuation Primary · From first dose to 100 days after last dose of study therapy (up to approximately 2 years)

The number of participants experiencing adverse events (AEs) leading to discontinuation to assess the safety and tolerability of BMS-986205 An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	5

Number of Participant Deaths Primary · From first dose to 100 days after last dose of study therapy (up to approximately 2 years)

The number of participants who died in each arm during the study to assess the safety and tolerability of BMS-986205.

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	3

The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests Primary · From first dose to 100 days after last dose of study therapy (up to approximately 2 years)

The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units to assess the safety and tolerability of BMS-986205. The number of participants with the following laboratory abnormalities will be summarized: ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN Total bilirubin \> 1.5 x ULN and 2 x ULN Concurrent (within 1 day) ALT or AST \> 3 x ULN with total bilirubin \> 2 x ULN Concurrent (within 30 days) ALT or AST \> 3 x ULN with total bilirubin \> 2 x ULN

ALT OR AST > 3XULN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	3

ALT OR AST> 5XULN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	2

ALT OR AST> 10XULN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	0

ALT OR AST > 20XULN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	0

TOTAL BILIRUBIN > 1.5XULN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	2

TOTAL BILIRUBIN > 2XULN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	1

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	0

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	0

The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests Primary · From first dose to 100 days after last dose of study therapy (up to approximately 2 years)

The number of participants with clinical laboratory test abnormalities based on US conventional units to assess the safety and tolerability of BMS-986205. The number of subjects with the following laboratory abnormalities will be summarized: TSH \> ULN WITH TSH \<= ULN AT BASELINE WITH AT LEAST ONE FT3/FT4 TEST VALUE \< LLN (Within a 2-week window after the abnormal TSH test date) WITH ALL OTHER FT3/FT4 TEST VALUES \>= LLN (Within a 2-week window after the abnormal TSH test date) WITH FT3/FT4 TEST MISSING (Within a 2-week window after the abnormal TSH test date) TSH \< LLN WITH TSH \>= LLN A

TSH > ULN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	4

TSH > ULN WITH TSH <= ULN AT BASELINE

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	4

TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	2

TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	4

TSH > ULN WITH FT3/FT4 TEST MISSING

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	0

TSH < LLN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	5

TSH <LLN WITH TSH >= LLN AT BASELINE

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	4

TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	0

(Cmax) Maximum Observed Plasma Concentration Primary · pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1

The maximum observes plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab.

C0D1

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	596.0	± 44.138

C0D14

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	701.9	± 24.870

C1D1

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	781.0	± 18.933

(Tmax) Time of Maximum Observed Plasma Concentration Primary · pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1

The time of maximum observed plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab.

C0D1

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	2.5	1 – 3

C0D14

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	2.5	2 – 4

C1D1

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	2.5	1.1 – 4

(AUC(TAU)) Area Under the Concentration-time Curve in One Dosing Interval Primary · pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1

The area under the concentration-time curve in one dosing interval was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab.

C0D1

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	3380.8	± 34.754

C0D14

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	6048.3	± 38.830

C1D1

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	5922.3	± 32.572

(CLT/F) Apparent Total Body Clearance Primary · pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14, Cycle 1 day 1

The apparent total body clearance was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab.

CYCLE0 DAY14

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	16.5	± 38.830

CYCLE1 DAY1

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	16.9	± 32.572

(T-HALF (Eff, AUC)) Effective Elimination Half-life Primary · pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14

The effective elimination half-life was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. T-HALF (eff, AUC) explains the degree of AUC accumulation observed.

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	22.9	± 9.40

(AI_CMAX) Accumulation Index Primary · pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14

The accumulation index was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. AI is calculated based on ratio of Cmax at steady state to after the first dose.

Group	Value	95% CI
BMS-986205 in Combination With Nivolumab	1.2	± 42.479

Adverse events — posted to ClinicalTrials.gov

Time frame: First dose and 100 days after last dose of study therapy (Up to approximately 2 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BMS-986205 in Combination With Nivolumab

Serious: 3/12 (25%)

Deaths: 3/12

Serious adverse events (4 terms)

Reaction	System	BMS-986205 in Combination …
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Tuberculosis	Infections and infestations	—
Acute kidney injury	Renal and urinary disorders	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (51 terms — click to expand)

Reaction	System	BMS-986205 in Combination …
Anaemia	Blood and lymphatic system disorders	—
Aspartate aminotransferase increased	Investigations	—
Alanine aminotransferase increased	Investigations	—
Leukopenia	Blood and lymphatic system disorders	—
Blood bilirubin increased	Investigations	—
Hypothyroidism	Endocrine disorders	—
Constipation	Gastrointestinal disorders	—
Blood alkaline phosphatase increased	Investigations	—
Platelet count decreased	Investigations	—
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Neutropenia	Blood and lymphatic system disorders	—
Blood creatinine increased	Investigations	—
Blood lactate dehydrogenase increased	Investigations	—
Blood thyroid stimulating hormone increased	Investigations	—
Gamma-glutamyltransferase increased	Investigations	—
Weight decreased	Investigations	—
Decreased appetite	Metabolism and nutrition disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Leukocytosis	Blood and lymphatic system disorders	—
Thrombocytopenia	Blood and lymphatic system disorders	—
Uveitis	Eye disorders	—
Abdominal distension	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Haematochezia	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Malaise	General disorders	—
Oedema peripheral	General disorders	—
Pyrexia	General disorders	—
Conjunctivitis	Infections and infestations	—
Pneumonia	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Blood creatine phosphokinase increased	Investigations	—
Blood thyroid stimulating hormone decreased	Investigations	—
C-reactive protein increased	Investigations	—
Myoglobin blood increased	Investigations	—
Neutrophil count decreased	Investigations	—
Neutrophil count increased	Investigations	—
Thyroxine increased	Investigations	—
White blood cell count decreased	Investigations	—

Most-reported serious reactions: Malignant neoplasm progression, Tuberculosis, Acute kidney injury, Pneumonitis.

Data from ClinicalTrials.gov NCT03792750 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors in clinical trials for cancer immunotherapy.
Tang K, Wu YH, Song Y, Yu B. · · 2021 · cited 276× · PMID 33883013 · DOI 10.1186/s13045-021-01080-8
Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
Trial watch: IDO inhibitors in cancer therapy.
Le Naour J, Galluzzi L, Zitvogel L, Kroemer G, et al · · 2020 · cited 133× · PMID 32934882 · DOI 10.1080/2162402x.2020.1777625
Targeting Tryptophan Catabolism in Cancer Immunotherapy Era: Challenges and Perspectives.
Peyraud F, Guegan JP, Bodet D, Cousin S, et al · · 2022 · cited 94× · PMID 35173722 · DOI 10.3389/fimmu.2022.807271
Small molecule-based immunomodulators for cancer therapy.
Wu Y, Yang Z, Cheng K, Bi H, et al · · 2022 · cited 71× · PMID 36562003 · DOI 10.1016/j.apsb.2022.11.007
Targeting Indoleamine Dioxygenase and Tryptophan Dioxygenase in Cancer Immunotherapy: Clinical Progress and Challenges.
Peng X, Zhao Z, Liu L, Bai L, et al · · 2022 · cited 38× · PMID 35965963 · DOI 10.2147/dddt.s373780
The Role of Indoleamine 2, 3-Dioxygenase 1 in Regulating Tumor Microenvironment.
Huang X, Zhang F, Wang X, Liu K. · · 2022 · cited 38× · PMID 35681736 · DOI 10.3390/cancers14112756
Tryptophan Metabolism Disorder-Triggered Diseases, Mechanisms, and Therapeutic Strategies: A Scientometric Review.
Chen X, Xu D, Yu J, Song XJ, et al · · 2024 · cited 26× · PMID 39408347 · DOI 10.3390/nu16193380

Verify or expand the search:

Other trials of BMS-986205

Trials testing the same drug.

NCT04007588 — A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) a · Phase 2 · withdrawn
NCT03936374 — A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants · Phase 1 · completed
NCT03519256 — A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG · Phase 2 · terminated
NCT03459222 — An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spre · Phase 1, PHASE2 · completed
NCT03417037 — An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared · Phase 3 · withdrawn

Other recruiting trials for Advanced Cancer

Currently open trials in the same condition.

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Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03792750 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 28 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03792750.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03792750

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of BMS-986205

Other recruiting trials for Advanced Cancer

Other Bristol-Myers Squibb trials

Verify against primary sources