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CompletedNCT04021043Updated Dec 3, 2025Results posted

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

A Phase 1/2 interventional study of Anti-GITR Agonistic Monoclonal Antibody BMS-986156 and Ipilimumab in Advanced Malignant Solid Neoplasm, Metastatic Carcinoma in the Liver and Metastatic Carcinoma in the Lung, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by M.D. Anderson Cancer Center · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
51
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the safe dose of BMS-986156 and dose limiting toxicities (DLT) (30 mg versus [vs] 100 mg) when combined with ipilimumab (3 mg/kg) for patients with metastatic cancer.

II. To evaluate the safety and toxicity profile of ipilimumab (3mg/kg) with BMS-986156 (30 or 100 mg) administered in combination with stereotactic body radiation therapy (SBRT) targeting 1-4 LIVER lesion(s) for patients with metastatic cancers.

III. To evaluate the safety and toxicity profile of ipilimumab (3mg/kg) with BMS-986156 (30 or 100 mg) administered in combination with SBRT targeting 1-4 LUNG lesion(s) for patients with metastatic cancer.

IV. To determine safety and toxicity profile of nivolumab (480 mg) with BMS-986156 (30 mg) administered in combination with SBRT targeting 1-4 LIVER lesion(s) for patients with metastatic cancers.

V. To determine safety and toxicity profile of nivolumab (480 mg) with BMS-986156 (30 mg) administered in combination with SBRT targeting 1-4 LUNG lesion(s) for patients with metastatic cancers.

SECONDARY OBJECTIVES:

I. To determine antitumor activity of ipilimumab therapy with BMS-986156 (30 or 100 mg) as well as nivolumab with BMS-986156 (30 mg) with SBRT treatment for 1-4 lung lesions in both the SBRT treated lesion and non-irradiate tumors.

II. To determine antitumor activity of ipilimumab therapy with or without BMS-986156 (30 or 100 mg) as well as nivolumab with BMS-986156 (30 mg) with SBRT treatment for 1-4 liver lesions in both the SBRT treated lesion and non-irradiate tumors.

III. To compare response and progression of the non-irradiated tumors between BMS-986156 with ipilimumab vs BMS-986156 with nivolumab, using both immune-related response criteria (irRC) and Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.1.

IV. To evaluate the predictive potential value of tumor-associated and systemic immune biomarkers for therapy effectiveness and toxicity prediction.

V. To evaluate whether skeletal mass, neutrophil, neutrophil to lymphocyte ratio, and tumor bulk are correlated with clinical outcomes and adverse events.

VI. To evaluate whether tumor kinetics in combination with clinical correlates can help determine treatment response.

VII. To evaluate whether tumor mutational burden correlates with improved clinical outcomes and response criteria.

OUTLINE: This is a phase I, dose-escalation study of anti-GITR agonistic monoclonal antibody BMS-986156, followed by a phase II study. Patients are assigned to 1 of 3 groups.

GROUP I: Patients receive ipilimumab intravenously (IV) over 90 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning day 1 of cycle 5 (day 85), patients receive nivolumab IV over 30 minutes. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive ipilimumab IV over 90 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 2, patients then undergo SBRT on days 29-32 for 4 fractions or on days 29-40 for 10 fractions. Beginning day 1 of cycle 5 (day 85), patents receive nivolumab IV over 30 minutes. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.

GROUP III: Patients receive nivolumab IV over 30 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 over 60 minutes on day 1. Patients also undergo SBRT over 30-45 minutes on days 1-4 for 4 fractions or on days 1-12 for 10 fractions. Treatment repeats every 28 days for up to 26 cycles of nivolumab and for up to 4 cycles of anti-GITR agonistic monoclonal antibody BMS-986156 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then every 2-4 months for up to 1 year.

02

Conditions studied

  • 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

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03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 51 is close to the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have histological confirmation of solid metastatic cancer with at least one metastatic or primary lesion in the liver or lung/chest, except for group 1.
  • Patients who have completed prior systemic anti-cancer therapies, an interval of 5 drug half-lives or 4-weeks whichever is shorter, is required, prior to enrollment on study. Note: patients with anaplastic thyroid will be waived from this inclusion criteria given the rapid trajectory of their disease
  • All patients must have at least one metastatic or primary lesion within the lung/chest or liver located in an anatomical location amenable to SBRT treatment with 50 Gy in 4 fractions or with 60 Gy in 10 fractions, except for group 1.
  • Repeat radiation in fields previously radiated will be allowed at the discretion of the treating physician
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky > 60%)
  • Total bilirubin =\< 2.0 mg/dL (does NOT apply to patients with Gilbert's syndrome) (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) \< 2.5 x institutional upper limit of normal (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
  • White blood count (WBC) >= 2500/uL (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
  • Absolute neutrophil count (ANC) >= 1000/uL (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
  • Platelets >= 75K (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
  • Hemoglobin >= 9 g/dL (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
  • Creatinine =\< 2.0 x upper limit of normal (ULN) (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
  • Patients must be willing and able to review, understand, and provide written consent before starting therapy
  • Patients with brain metastasis will be included as long as they are free of neurologic symptoms related to metastatic brain lesions and who do not require or receive systemic corticosteroid therapy, > 10 mg/day in the 14 days prior to beginning the trial (=\< 10 mg steroid, e.g.: prednisone, is allowed). Patients with stable brain metastases (clinically and radiographically) for >= 4 weeks to enroll on the protocol.
  • Patients that have previously progressed on immunotherapy such as ipilimumab, anti-PD-I, anti-PDL-1 or talimogene laherparepvec (T-VEC) will be eligible.

Exclusion criteria

Exclusion Criteria:

  • Serious autoimmune disease at the discretion of the treating attending: patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's granulomatosis) are excluded from this study
  • Active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation
  • Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events (AEs): e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C that has not been documented to be stable
  • Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab)
  • Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids while receiving ipilimumab (as long as steroid replacement is significantly greater than what is required for physiologic replacement, i.e. in hypothyroidism)
  • Pregnant women are excluded from this study. Women of child-bearing potential (WOCBP) must have a pregnancy test every 4 weeks and WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of immunotherapy drugs (ipilimumab/nivolumab/BMS-986156), during the course of the treatment and 160 days AFTER the last dose of study drug you should not get pregnant or breast feed. In the case of male participants, during the course of treatment and 220 days AFTER the last dose of immunotherapy you should not father a child (condom use is mandatory, even if vasectomized) or donate sperm. For contraception guidelines please see protocol
  • History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
  • Prior allogeneic stem cell transplantation
  • Patients who were intolerant to previous immuno-oncology (IO) drugs should be excluded
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Group I (ipilimumab, BMS-986156, nivolumab)

    Patients receive ipilimumab IV over 90 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning day 1 of cycle 5 (day 85), patients receive nivolumab IV over 30 minutes. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.

    Drug: Anti-GITR Agonistic Monoclonal Antibody BMS-986156 · Biological: Ipilimumab · Biological: Nivolumab

  • Experimental
    Group II (ipilimumab, BMS-986156, SBRT, nivolumab)

    Patients receive ipilimumab IV over 90 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 2, patients then undergo SBRT on days 29-32 for 4 fractions or on days 29-40 for 10 fractions. Beginning day 1 of cycle 5 (day 85), patents receive nivolumab IV over 30 minutes. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.

    Drug: Anti-GITR Agonistic Monoclonal Antibody BMS-986156 · Biological: Ipilimumab · Biological: Nivolumab · Radiation: Stereotactic Body Radiation Therapy

  • Experimental
    Group III (nivolumab, BMS-986156, SBRT)

    Patients receive nivolumab IV over 30 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 over 60 minutes on day 1. Patients also undergo SBRT over 30-45 minutes on days 1-4 for 4 fractions or on days 1-12 for 10 fractions. Treatment repeats every 28 days for up to 26 cycles of nivolumab and for up to 4 cycles of anti-GITR agonistic monoclonal antibody BMS-986156 in the absence of disease progression or unacceptable toxicity.

    Drug: Anti-GITR Agonistic Monoclonal Antibody BMS-986156 · Biological: Nivolumab · Radiation: Stereotactic Body Radiation Therapy

Interventions

  • DrugAnti-GITR Agonistic Monoclonal Antibody BMS-986156

    Given IV

    Also known as: Anti-GITR MoAb BMS-986156, BMS 986156, BMS-986156, GITR Agonist BMS-986156, TNFRSF18 Agonist BMS-986156

  • BiologicalIpilimumab

    Given IV

    Also known as: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4, Yervoy

  • BiologicalNivolumab

    Given IV

    Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo

  • RadiationStereotactic Body Radiation Therapy

    Undergo SBRT

    Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

06

What researchers measure

Primary outcomes

  1. Number of Dose Limiting Toxicities (DLTs)

    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

    Time frame: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

Secondary outcomes

  1. Assess SBRT and Palliative Radiation Completion

    Explore antitumor activity with SBRT and palliative radiation.

    Time frame: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

  2. Immune-related Tumor Response

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

    Time frame: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

  3. Out-of-field (Abscopal) Disease Control Rate (ACR)

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

    Time frame: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

  4. Out-of-field (Abscopal) Response Rate (ARR)

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

    Time frame: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

  5. Tumor Burden: Disease Control Rate

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

    Time frame: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)

07

Results

Posted Dec 3, 2025

Participant flow

Dates of recruitment period: 08/2019 to 12/2021; Location: Single center trial that recruited patients at one hospital site (MD Anderson Cancer Center, Houston, TX)

Participant flow — Overall Study
MilestoneIpilimumab + BMS-986156 (30 mg/kg) ArmIpilimumab + BMS-986156 (100 mg/kg) ArmIpilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT Arm
Started10101020
Completed0001
Not completed10101019
Withdrew: Adverse event3110
Withdrew: Death2313
Withdrew: Withdrawal by subject1116
Withdrew: Discontinued due to disease progression45710

Outcome measures

PrimaryNumber of Dose Limiting Toxicities (DLTs)

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

Time frame:
Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)
Reported as:
Number · Dose limiting toxicities
Number of Dose Limiting Toxicities (DLTs)
Dose limiting toxicitiesIpilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT Arm
Number of Dose Limiting Toxicities (DLTs)1100
SecondaryAssess SBRT and Palliative Radiation Completion

Explore antitumor activity with SBRT and palliative radiation.

Time frame:
Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)
Reported as:
Number · Count of participants
Assess SBRT and Palliative Radiation Completion
Count of participantsIpilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT Arm
Completion of SBRT without interruption due to RT-related AEs——1020
Re-induction of SBRT due to progression per protocol——04
Received palliative RT while receiving immunotherapy——03
Received palliative RT after finishing all protocol-specified therapy——25
SecondaryImmune-related Tumor Response

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

Time frame:
Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)
Reported as:
Number · Count of participants
Immune-related Tumor Response
Count of participantsIpilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT Arm
Immune Related Stable Disease (irSD)2147
Immune Related Partial Response (irPR)1002
Immune Related Progressive Disease (irPD)15514
SecondaryOut-of-field (Abscopal) Disease Control Rate (ACR)

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

Time frame:
Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)
Reported as:
Number · Count of participants
Out-of-field (Abscopal) Disease Control Rate (ACR)
Count of participantsIpilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT Arm
Abscopal control rate——79
Disease control rate——17
SecondaryOut-of-field (Abscopal) Response Rate (ARR)

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

Time frame:
Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)
Reported as:
Number · Count of participants
Out-of-field (Abscopal) Response Rate (ARR)
Count of participantsIpilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT Arm
Objective Response Rate (ORR)1002
Abscopal response rate (ARR)NANA02
SecondaryTumor Burden: Disease Control Rate

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

Time frame:
Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)
Reported as:
Number · Count of participants
Tumor Burden: Disease Control Rate
Count of participantsIpilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT Arm
Tumor Burden: Disease Control Rate33411

Adverse events

Collected over Baseline to at least 100 days after the last dose of study treatment, up to 5 years.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ipilimumab + BMS-986156 Arm (30 mg/kg)2/10 (20%)6/10 (60%)10/10 (100%)
Ipilimumab + BMS-986156 Arm (100 mg/kg)3/10 (30%)10/10 (100%)10/10 (100%)
Ipilimumab + BMS-986156 With SBRT Arm1/10 (10%)5/10 (50%)10/10 (100%)
Nivolumab + BMS-986156 With SBRT Arm3/20 (15%)9/20 (45%)20/20 (100%)
Most frequent serious events
Showing 10 of 40
Most frequent serious events
EventIpilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT Arm
Death NOSGeneral disorders5/101/103/103/20
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify *General disorders3/102/101/101/20
ColitisGastrointestinal disorders1/102/100/100/20
DyspneaRespiratory, thoracic and mediastinal disorders2/100/102/102/20
PneumonitisRespiratory, thoracic and mediastinal disorders2/101/100/100/20
Hepatobiliary disorders - Other, specifyGastrointestinal disorders0/100/102/102/20
Thromboembolic eventVascular disorders2/100/100/100/20
DiarrheaGastrointestinal disorders1/101/100/100/20
FatigueGeneral disorders1/100/100/100/20
HypercalcemiaMusculoskeletal and connective tissue disorders1/100/100/100/20
Most frequent other events
Showing 10 of 98
Most frequent other events
EventIpilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT Arm
DyspneaRespiratory, thoracic and mediastinal disorders7/102/1010/1010/20
Back painGeneral disorders5/100/109/109/20
RashSkin and subcutaneous tissue disorders8/101/104/104/20
FatigueGeneral disorders7/102/107/107/20
Abdominal painGeneral disorders6/102/107/107/20
Chest wall painGeneral disorders0/102/107/107/20
AnorexiaGeneral disorders5/103/106/106/20
DiarrheaGastrointestinal disorders6/103/103/103/20
CoughRespiratory, thoracic and mediastinal disorders6/101/104/104/20
Generalized muscle weaknessMusculoskeletal and connective tissue disorders6/100/104/104/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Ipilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT ArmTotal
Median59 (51 to 71)61 (49 to 77)65 (52 to 70)60 (52 to 68)61 (52 to 70)
Sex: Female, Male
Sex: Female, Male(Participants)Ipilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT ArmTotal
Female654520
Male4561530
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Ipilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT ArmTotal
Hispanic or Latino20013
Not Hispanic or Latino810101947
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Ipilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT ArmTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American10113
White71091844
More than one race00000
Unknown or Not Reported20013
Region of Enrollment
Region of Enrollment(participants)Ipilimumab + BMS-986156 Arm (30 mg/kg)Ipilimumab + BMS-986156 Arm (100 mg/kg)Ipilimumab + BMS-986156 With SBRT ArmNivolumab + BMS-986156 With SBRT ArmTotal
United States1010102050
08

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Publications

  • Chang JY, Xu X, Shroff GS, Comeaux NI, Li W, Rodon Ahnert J, Karp DD, Dumbrava EE, Verma V, Chen A, Welsh J, Hong DS. Phase I/II study of BMS-986156 with ipilimumab or nivolumab with or without stereotactic ablative radiotherapy in patients with advanced solid malignancies. J Immunother Cancer. 2024 Oct 9;12(10):e009975. doi: 10.1136/jitc-2024-009975. PubMed 39384194 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 14, 2020
  • Informed consent form · Apr 15, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04021043
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jul 16, 2019
Start date
Aug 19, 2019
Primary completion
Apr 14, 2025
Completion
Apr 14, 2025
Results posted
Dec 3, 2025
Last update
Dec 3, 2025

Study contacts

Joe Chang
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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