New combo therapy aims to supercharge immune attack on tough cancers
NCT ID NCT04021043
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a combination of three immunotherapy drugs (ipilimumab, nivolumab, and BMS-986156) with or without precise radiation therapy in 51 people with advanced solid cancers that had spread to the liver or lungs. The goal was to find the safest dose of BMS-986156 and see if adding radiation helps the immune system fight tumors better. The trial is complete, but results are not yet reported.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Immunotherapy drugs (ipilimumab, nivolumab, BMS-986156) and stereotactic body radiation therapy
- What this could lead to
- If it works, this could point toward a more effective treatment combination for advanced cancers that have spread to the liver or lungs.
- What could go wrong
- This is an early-phase trial with only 51 participants, so results may not apply to everyone. The combination may cause significant side effects or not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
51 people
The number who actually took part.
- Started
-
Aug 2019
- Finished
-
Apr 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced malignant solid neoplasm are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new radiation method tackle multiple tumors at once?
- Can a protein calm the immune System's overreaction to cancer treatment?
- Can a tracer that hunts unstable iron light up hidden tumors?
- New drug combo aims to shrink Hard-to-Treat pancreatic and ovarian tumors
- Engineered immune cells take aim at Hard-to-Treat cancers
- Vaccine trains immune system to hunt down cancer cells