NCT04349267

Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

Completed Phase 1, PHASE2 Results posted Last updated 17 December 2025

What this trial tests

Phase 1, PHASE2 trial testing BMS-986315 in Advanced Solid Tumor in 44 participants. Completed in 22 August 2024.

Timeline

14 July 2020

Primary endpoint
22 August 2024

22 August 2024

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	14 July 2020
Primary completion	22 August 2024
Estimated completion	22 August 2024
Sites	8 locations across Canada, United States, Mexico

Drugs / interventions tested

• BMS-986315 — full drug profile →
• nivolumab (nivolumab) — full drug profile →
• cetuximab (cetuximab) — full drug profile →

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor. 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.

Number of Participants With Adverse Events and Deaths Primary · From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hos

Any adverse events

Group	Value	95% CI
Part 1A BMS-986315-80 mg	2
Part 1A BMS-986315-200 mg	2
Part 1A BMS-986315-600 mg	3
Part 1A BMS-986315-1200 mg	3
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	5
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	14
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	15

Serious Adverse Events

Group	Value	95% CI
Part 1A BMS-986315-80 mg	0
Part 1A BMS-986315-200 mg	2
Part 1A BMS-986315-600 mg	0
Part 1A BMS-986315-1200 mg	0
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	3
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	8
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	10

AEs leading to discontinuation

Group	Value	95% CI
Part 1A BMS-986315-80 mg	0
Part 1A BMS-986315-200 mg	1
Part 1A BMS-986315-600 mg	0
Part 1A BMS-986315-1200 mg	0
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	0
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	2
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	2

Deaths

Group	Value	95% CI
Part 1A BMS-986315-80 mg	1
Part 1A BMS-986315-200 mg	1
Part 1A BMS-986315-600 mg	0
Part 1A BMS-986315-1200 mg	0
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	1
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	2
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	4

Number of Participants With Dose Limiting Toxicities (DLTs) Primary · From first dose (Day 1) untill Day 28

A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.

Group	Value	95% CI
Part 1A BMS-986315-80 mg	0
Part 1A BMS-986315-200 mg	0
Part 1A BMS-986315-600 mg	0
Part 1A BMS-986315-1200 mg	0
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	0
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	0
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	0

Objective Response Rate (ORR) Secondary · From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)

ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions

Group	Value	95% CI
Part 1A BMS-986315-80 mg	0.0	0.0 – 84.2
Part 1A BMS-986315-200 mg	0.0	0.0 – 84.2
Part 1A BMS-986315-600 mg	0.0	0.0 – 70.8
Part 1A BMS-986315-1200 mg	0.0	0.0 – 70.8
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	0.0	0.0 – 52.2
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	7.1	0.2 – 33.9
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	0.0	0.0 – 21.8

Duration of Response (DoR) Secondary · From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)

DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of targ

Group	Value	95% CI
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	NA	NA – NA

Progression Free Survival (PFS) Rate Secondary · At 6 months

Progression Free Survival Rates at 6 months is defined as the percentage of participants who achieve PFS at 6 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if tha

Group	Value	95% CI
Part 1A BMS-986315-80 mg	0
Part 1A BMS-986315-200 mg	0
Part 1A BMS-986315-600 mg	0
Part 1A BMS-986315-1200 mg	0
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	0
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	0
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	0

Maximum Plasma Concentration (Cmax) of BMS-986315 Secondary · Cycle 1 Day 1

Blood samples were collected to assess pharmacokinetic (PK) parameters.

Group	Value	95% CI
Part 1A BMS-986315-80 mg	28.8519	± 40
Part 1A BMS-986315-200 mg	51.9309	± 13
Part 1A BMS-986315-600 mg	168.2658	± 3
Part 1A BMS-986315-1200 mg	283.6735	± 66
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	63.1812	± 15
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	160.8894	± 35
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	309.0469	± 24

Time to Maximum Plasma Concentration (Tmax) of BMS-986315 Secondary · Cycle 1 Day 1

Blood samples were collected to assess pharmacokinetic (PK) parameters.

Group	Value	95% CI
Part 1A BMS-986315-80 mg	2.1916	± 168
Part 1A BMS-986315-200 mg	2.5151	± 84
Part 1A BMS-986315-600 mg	1.0747	± 10
Part 1A BMS-986315-1200 mg	1.8572	± 104
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	1.4213	± 63
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	3.5165	± 249
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	1.9030	± 78

Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of BMS-986315 Secondary · Cycle 1 Day 1

Blood samples were collected to assess pharmacokinetic (PK) parameters.

Group	Value	95% CI
Part 1A BMS-986315-80 mg	6885.1959	± 33
Part 1A BMS-986315-200 mg	12122.1650	± 18
Part 1A BMS-986315-600 mg	41381.3449	± 12
Part 1A BMS-986315-1200 mg	62500.0455	± 56
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	12885.5705	± 20
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	36893.5416	± 32
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	62110.3402	± 33

Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) of BMS-986315 Secondary · Cycle 1 Day 1

Blood samples were collected to assess pharmacokinetic (PK) parameters.

Group	Value	95% CI
Part 1A BMS-986315-80 mg	6345.4606	± 21
Part 1A BMS-986315-200 mg	13113.1903	± 6
Part 1A BMS-986315-600 mg	41381.3449	± 12
Part 1A BMS-986315-1200 mg	62500.0455	± 56
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	12885.5705	± 20
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	36893.5416	± 32
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	70405.3800	± 29

Concentration in a Dosing Interval (Ctau) of BMS-986315 Secondary · Cycle 1 Day 1

Blood samples were collected to assess pharmacokinetic (PK) parameters.

Group	Value	95% CI
Part 1A BMS-986315-80 mg	4.4119	± 20
Part 1A BMS-986315-200 mg	10.7013	± 23
Part 1A BMS-986315-600 mg	33.1011	± 4
Part 1A BMS-986315-1200 mg	51.1321	± 66
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	10.5418	± 26
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	28.3387	± 40
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	49.2124	± 48

Number of Participants With Anti-Drug Antibody (ADA) Secondary · Cycle 1 Day 1

An ADA positive participant was defined as participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment.

BMS986315 ADA

Group	Value	95% CI
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	0
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	0
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	0

Nivolumab ADA

Group	Value	95% CI
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	0
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	0
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	1

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1A BMS-986315-80 mg

Serious: 0/2 (0%)

Deaths: 1/2

Part 1A BMS-986315-200 mg

Serious: 2/2 (100%)

Deaths: 1/2

Part 1A BMS-986315-600 mg

Serious: 0/3 (0%)

Deaths: 3/3

Part 1A BMS-986315-1200 mg

Serious: 0/3 (0%)

Deaths: 2/3

Part 1B BMS-986315-200 mg + Nivolumab 480 mg

Serious: 3/5 (60%)

Deaths: 4/5

Part 1B BMS-986315-600 mg + Nivolumab 480 mg

Serious: 8/14 (57%)

Deaths: 7/14

Part 1B BMS-986315-1200 mg + Nivolumab 480 mg

Serious: 10/15 (67%)

Deaths: 14/15

Serious adverse events (25 terms)

Reaction	System	Part 1A BMS-986315-80 mg	Part 1A BMS-986315-200 mg	Part 1A BMS-986315-600 mg	Part 1A BMS-986315-1200 mg	Part 1B BMS-986315-200 mg …	Part 1B BMS-986315-600 mg …	Part 1B BMS-986315-1200 mg…
Pneumonia	Infections and infestations	—	—	—	—	—	—	—
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—	—	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—	—	—	—	—
Sudden death	General disorders	—	—	—	—	—	—	—
Arthritis infective	Infections and infestations	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—
Ludwig angina	Infections and infestations	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—
Joint dislocation	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Post procedural complication	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Metastases to spinal cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Encephalopathy	Nervous system disorders	—	—	—	—	—	—	—
VIth nerve disorder	Nervous system disorders	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Pharyngeal stenosis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—	—	—	—	—

Other adverse events (177 terms — click to expand)

Reaction	System	Part 1A BMS-986315-80 mg	Part 1A BMS-986315-200 mg	Part 1A BMS-986315-600 mg	Part 1A BMS-986315-1200 mg	Part 1B BMS-986315-200 mg …	Part 1B BMS-986315-600 mg …	Part 1B BMS-986315-1200 mg…
Fatigue	General disorders	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—
Candida infection	Infections and infestations	—	—	—	—	—	—	—
Oral candidiasis	Infections and infestations	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Pain in jaw	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Neuropathy peripheral	Nervous system disorders	—	—	—	—	—	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Skin ulcer	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Hot flush	Vascular disorders	—	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Malignant neoplasm progression, Anaemia, Pericardial effusion, Supraventricular tachycardia, Sudden death, Arthritis infective, Cellulitis.

Data from ClinicalTrials.gov NCT04349267 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

Publications & conference data

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

1. Disruption of the NKG2A:HLA-E Immune Checkpoint Axis to Enhance NK Cell Activation against Cancer.
   Fisher JG, Doyle ADP, Graham LV, Khakoo SI, et al · · 2022 · cited 47× · PMID 36560403 · DOI 10.3390/vaccines10121993
2. The Right Partner in Crime: Unlocking the Potential of the Anti-EGFR Antibody Cetuximab <i>via</i> Combination With Natural Killer Cell Chartering Immunotherapeutic Strategies.
   Baysal H, De Pauw I, Zaryouh H, Peeters M, et al · · 2021 · cited 41× · PMID 34557197 · DOI 10.3389/fimmu.2021.737311
3. Immune deserts in head and neck squamous cell carcinoma: A review of challenges and opportunities for modulating the tumor immune microenvironment.
   Farlow JL, Brenner JC, Lei YL, Chinn SB. · · 2021 · cited 34× · PMID 34218062 · DOI 10.1016/j.oraloncology.2021.105420
4. Unlocking the therapeutic potential of the NKG2A-HLA-E immune checkpoint pathway in T cells and NK cells for cancer immunotherapy.
   Li Y, Li Z, Tang Y, Zhuang X, et al · · 2024 · cited 26× · PMID 39486805 · DOI 10.1136/jitc-2024-009934
5. PD-1/PD-L1 inhibitors-based treatment for advanced renal cell carcinoma: Mechanisms affecting efficacy and combination therapies.
   Ding L, Dong HY, Zhou TR, Wang YH, et al · · 2021 · cited 15× · PMID 34382349 · DOI 10.1002/cam4.4190
6. Harnessing natural killer cell effector function against cancer.
   Blunt MD, Khakoo SI. · · 2024 · cited 8× · PMID 38223411 · DOI 10.1093/immadv/ltad031