Who is sponsoring NCT04021043?

NCT04021043 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT04021043?

Interventions in NCT04021043: Anti-GITR Agonistic Monoclonal Antibody BMS-986156, Ipilimumab, Nivolumab, Stereotactic Body Radiation Therapy.

What condition does NCT04021043 study?

NCT04021043 studies Advanced Malignant Solid Neoplasm, Metastatic Carcinoma in the Liver, Metastatic Carcinoma in the Lung, Metastatic Malignant Neoplasm in the Thoracic Cavity, Metastatic Malignant Solid Neoplasm.

Is NCT04021043 still recruiting?

NCT04021043 is currently completed. Last updated 3 December 2025.

Are results published for NCT04021043?

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

Last reviewed 2025-12-03 · How we verify

NCT04021043

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

BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers

Completed Phase 1, PHASE2 Results posted Last updated 3 December 2025

What this trial tests

Phase 1, PHASE2 trial testing Anti-GITR Agonistic Monoclonal Antibody BMS-986156 in Advanced Malignant Solid Neoplasm in 51 participants. Completed in 14 April 2025.

Timeline

19 August 2019

Primary endpoint
14 April 2025

14 April 2025

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	19 August 2019
Primary completion	14 April 2025
Estimated completion	14 April 2025
Sites	1 location across United States

Drugs / interventions tested

Anti-GITR Agonistic Monoclonal Antibody BMS-986156
Ipilimumab — full drug profile →
Nivolumab (nivolumab) — full drug profile →
Stereotactic Body Radiation Therapy — full drug profile →

Conditions studied

Advanced Malignant Solid Neoplasm — all drugs for Advanced Malignant Solid Neoplasm →
Metastatic Carcinoma in the Liver — all drugs for Metastatic Carcinoma in the Liver →
Metastatic Carcinoma in the Lung — all drugs for Metastatic Carcinoma in the Lung →
Metastatic Malignant Neoplasm in the Thoracic Cavity — all drugs for Metastatic Malignant Neoplasm in the Thoracic Cavity →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Advanced Malignant Solid Neoplasm or Metastatic Carcinoma in the Liver. 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 Dose Limiting Toxicities (DLTs) Primary · Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

Evaluate dose of BMS-986156 (30 mg vs 100 mg) and dose limiting toxicities (DLTs) when combined with ipilimumab (3 mg/kg), and evaluate DLTs when BMS-986156 administered in combination with ipilimumab (3 mg/kg) or nivolumab (480 mg) with SABR

Group	Value	95% CI
Ipilimumab + BMS-986156 Arm (30 mg/kg)	1
Ipilimumab + BMS-986156 Arm (100 mg/kg)	1
Ipilimumab + BMS-986156 With SBRT Arm	0
Nivolumab + BMS-986156 With SBRT Arm	0

Assess SBRT and Palliative Radiation Completion Secondary · Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

Explore antitumor activity with SBRT and palliative radiation.

Completion of SBRT without interruption due to RT-related AEs

Group	Value	95% CI
Ipilimumab + BMS-986156 With SBRT Arm	10
Nivolumab + BMS-986156 With SBRT Arm	20

Re-induction of SBRT due to progression per protocol

Group	Value	95% CI
Ipilimumab + BMS-986156 With SBRT Arm	0
Nivolumab + BMS-986156 With SBRT Arm	4

Received palliative RT while receiving immunotherapy

Group	Value	95% CI
Ipilimumab + BMS-986156 With SBRT Arm	0
Nivolumab + BMS-986156 With SBRT Arm	3

Received palliative RT after finishing all protocol-specified therapy

Group	Value	95% CI
Ipilimumab + BMS-986156 With SBRT Arm	2
Nivolumab + BMS-986156 With SBRT Arm	5

Immune-related Tumor Response Secondary · Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

Number of immune related responses of different immunotherapy schemes with or without SABR; Assessing complete response (CR), partial response (PR), and stable disease (SD)

Immune Related Stable Disease (irSD)

Group	Value	95% CI
Ipilimumab + BMS-986156 Arm (30 mg/kg)	2
Ipilimumab + BMS-986156 Arm (100 mg/kg)	1
Ipilimumab + BMS-986156 With SBRT Arm	4
Nivolumab + BMS-986156 With SBRT Arm	7

Immune Related Partial Response (irPR)

Group	Value	95% CI
Ipilimumab + BMS-986156 Arm (30 mg/kg)	1
Ipilimumab + BMS-986156 Arm (100 mg/kg)	0
Ipilimumab + BMS-986156 With SBRT Arm	0
Nivolumab + BMS-986156 With SBRT Arm	2

Immune Related Progressive Disease (irPD)

Group	Value	95% CI
Ipilimumab + BMS-986156 Arm (30 mg/kg)	1
Ipilimumab + BMS-986156 Arm (100 mg/kg)	5
Ipilimumab + BMS-986156 With SBRT Arm	5
Nivolumab + BMS-986156 With SBRT Arm	14

Out-of-field (Abscopal) Disease Control Rate (ACR) Secondary · Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

Patient's change of tumor since intiation of treatment and patient's exhibiting out of field disease control.

Abscopal control rate

Group	Value	95% CI
Ipilimumab + BMS-986156 With SBRT Arm	7
Nivolumab + BMS-986156 With SBRT Arm	9

Disease control rate

Group	Value	95% CI
Ipilimumab + BMS-986156 With SBRT Arm	1
Nivolumab + BMS-986156 With SBRT Arm	7

Out-of-field (Abscopal) Response Rate (ARR) Secondary · Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

Assesses partial response (PR) rate and complete response (CR) rate

Objective Response Rate (ORR)

Group	Value	95% CI
Ipilimumab + BMS-986156 Arm (30 mg/kg)	1
Ipilimumab + BMS-986156 Arm (100 mg/kg)	0
Ipilimumab + BMS-986156 With SBRT Arm	0
Nivolumab + BMS-986156 With SBRT Arm	2

Abscopal response rate (ARR)

Group	Value	95% CI
Ipilimumab + BMS-986156 Arm (30 mg/kg)	NA
Ipilimumab + BMS-986156 Arm (100 mg/kg)	NA
Ipilimumab + BMS-986156 With SBRT Arm	0
Nivolumab + BMS-986156 With SBRT Arm	2

Tumor Burden: Disease Control Rate Secondary · Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

Assessing complete response (CR), partial response (PR), and stable disease (SD)

Group	Value	95% CI
Ipilimumab + BMS-986156 Arm (30 mg/kg)	3
Ipilimumab + BMS-986156 Arm (100 mg/kg)	3
Ipilimumab + BMS-986156 With SBRT Arm	4
Nivolumab + BMS-986156 With SBRT Arm	11

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to at least 100 days after the last dose of study treatment, up to 5 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ipilimumab + BMS-986156 Arm (30 mg/kg)

Serious: 6/10 (60%)

Deaths: 2/10

Ipilimumab + BMS-986156 Arm (100 mg/kg)

Serious: 10/10 (100%)

Deaths: 3/10

Ipilimumab + BMS-986156 With SBRT Arm

Serious: 5/10 (50%)

Deaths: 1/10

Nivolumab + BMS-986156 With SBRT Arm

Serious: 9/20 (45%)

Deaths: 3/20

Serious adverse events (40 terms)

Reaction	System	Ipilimumab + BMS-986156 Ar…	Ipilimumab + BMS-986156 Ar…	Ipilimumab + BMS-986156 Wi…	Nivolumab + BMS-986156 Wit…
Death NOS	General disorders	—	—	—	—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify *	General disorders	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Hepatobiliary disorders - Other, specify	Gastrointestinal disorders	—	—	—	—
Thromboembolic event	Vascular disorders	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Hypercalcemia	Musculoskeletal and connective tissue disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Pelvic pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Delirium	Nervous system disorders	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—
Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Alanine aminotransferase increased	Gastrointestinal disorders	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—
Anorectal infection	Infections and infestations	—	—	—	—
Aspartate aminotransferase increased	Gastrointestinal disorders	—	—	—	—
Aspiration	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	—	—	—	—
Cardiac disorders - Other, specify	Cardiac disorders	—	—	—	—
Dehydration	General disorders	—	—	—	—

Other adverse events (98 terms — click to expand)

Reaction	System	Ipilimumab + BMS-986156 Ar…	Ipilimumab + BMS-986156 Ar…	Ipilimumab + BMS-986156 Wi…	Nivolumab + BMS-986156 Wit…
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Back pain	General disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Abdominal pain	General disorders	—	—	—	—
Chest wall pain	General disorders	—	—	—	—
Anorexia	General disorders	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	—	—	—	—
Aspartate aminotransferase increased	Gastrointestinal disorders	—	—	—	—
Edema limbs	Blood and lymphatic system disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Weight loss	Metabolism and nutrition disorders	—	—	—	—
General disorders and administration site conditions - Other, specify	General disorders	—	—	—	—
Alanine aminotransferase increased	Gastrointestinal disorders	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Creatinine increased	Renal and urinary disorders	—	—	—	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—
Fever	General disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Hypercalcemia	General disorders	—	—	—	—
Insomnia	General disorders	—	—	—	—
Hypothyroidism	General disorders	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—
Hypokalemia	General disorders	—	—	—	—
Dizziness	General disorders	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—
Headache	General disorders	—	—	—	—
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	—	—	—	—
Urinary frequency	Renal and urinary disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	—	—	—	—
Hypoxia	Cardiac disorders	—	—	—	—

Most-reported serious reactions: Death NOS, Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify *, Colitis, Dyspnea, Pneumonitis, Hepatobiliary disorders - Other, specify, Thromboembolic event, Diarrhea.

Data from ClinicalTrials.gov NCT04021043 adverse events section.

Sponsor's own description

This phase I/II trial studies the side effects and best dose of anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) agonistic monoclonal antibody BMS-986156 (BMS-986156) when given together with ipilimumab and nivolumab with or without stereotactic body radiation therapy and to see how well they work in treating patients with lung/chest or liver cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as BMS-986156, ipilimumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. It is not yet known whether giving BMS-986156, ipilimumab, and nivolumab with or without stereotactic body radiation therapy will work better in treating patients with lung/chest or liver cancers.

Publications & conference data

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

Regulatory T cells in tumor microenvironment: new mechanisms, potential therapeutic strategies and future prospects.
Li C, Jiang P, Wei S, Xu X, et al · · 2020 · cited 679× · PMID 32680511 · DOI 10.1186/s12943-020-01234-1
Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
Immunotherapy in Lung Cancer: Current Landscape and Future Directions.
Mamdani H, Matosevic S, Khalid AB, Durm G, et al · · 2022 · cited 253× · PMID 35222404 · DOI 10.3389/fimmu.2022.823618
Mechanisms of regulatory T cell infiltration in tumors: implications for innovative immune precision therapies.
Nishikawa H, Koyama S. · · 2021 · cited 227× · PMID 34330764 · DOI 10.1136/jitc-2021-002591
Targeting Treg cells with GITR activation alleviates resistance to immunotherapy in murine glioblastomas.
Amoozgar Z, Kloepper J, Ren J, Tay RE, et al · · 2021 · cited 153× · PMID 33976133 · DOI 10.1038/s41467-021-22885-8
Recent advances in systemic therapy for hepatocellular carcinoma.
Zhang H, Zhang W, Jiang L, Chen Y. · · 2022 · cited 150× · PMID 35000616 · DOI 10.1186/s40364-021-00350-4
T-cell agonists in cancer immunotherapy.
Choi Y, Shi Y, Haymaker CL, Naing A, et al · · 2020 · cited 90× · PMID 33020242 · DOI 10.1136/jitc-2020-000966
Resistance to immune checkpoint inhibitors in non-small cell lung cancer: biomarkers and therapeutic strategies.
Walsh RJ, Soo RA. · · 2020 · cited 77× · PMID 32670423 · DOI 10.1177/1758835920937902

Verify or expand the search:

Other recruiting trials for Advanced Malignant Solid Neoplasm

Currently open trials in the same condition.

NCT07141407 — Telephone-Based Coaching Sessions (TAC) to Improve Advance Care Planning Participation in Advanced Cancer Patients and T · NA · recruiting
NCT07189195 — TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory · Phase 1 · recruiting
NCT07174661 — Educational Tools for the Improvement of Early Advance Care Planning in Adolescents and Young Adults With Advanced Solid · NA · recruiting
NCT06223542 — Studying TAK-243 in Patients With Advanced Cancer · Phase 1 · recruiting
NCT06311214 — Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastati · Phase 2 · recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · 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 NCT04021043 (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 M.D. Anderson Cancer Center
Last refreshed: 3 December 2025

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/NCT04021043.

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