Experimental cocktail aims to revive immune attack on Hard-to-Treat cancers
NCT ID NCT03228667
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of an experimental immune booster (N-803) with standard checkpoint inhibitors in people with advanced solid tumors (like lung, bladder, or skin cancer) whose disease progressed after prior immunotherapy. The goal is to see if the combo can shrink tumors and improve survival. About 40 participants will receive the drugs by injection or IV every few weeks, and researchers will monitor safety and immune responses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- N-803 (nogapendekin alfa inbakicept) plus a checkpoint inhibitor (pembrolizumab, nivolumab, or atezolizumab)
- What this could lead to
- If successful, this combination could offer a new treatment option for patients whose cancers have stopped responding to standard immunotherapy, potentially shrinking tumors and extending survival.
- What could go wrong
- This is an early-phase (2b) trial with only 40 participants across many cancer types, so results may not apply broadly. The added drug N-803 may cause side effects like infusion reactions or immune-related inflammation, and the combination may not work better than existing therapies.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2018
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 (Cohort 6 only) 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant IRB/IEC guidelines. 3. Pathologically confirmed stage IV NSCLC disease. 4. Have received exactly 1 anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab) for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances) outlined below. Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. a. For those participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease: If they had disease progression within (≤) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease OR if they had disease progression more than (\>) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advanced disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease. 5. Have reported disease progression (in the opinion of the treating physician) more than (\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab). 6. Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease, must have had a best response of SD, PR or CR (in the opinion of the treating physician) on the anti- PD-1 or anti-PD-L1 therapy (either nivolumab or pembrolizumab) for stage IV or recurrent disease. 7. Participants with a known sensitizing mutation for which an - approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2 and MET sensitizing mutations), must have previously received at least 1 of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met. 8. ECOG performance status of 0 to 2. 9. Measurable tumor lesions according to RECIST v1.1. 10. Ability to attend required study visits and return for adequate follow-up, as required by this protocol. 11. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males. Female participants of child-bearing potential must agree to use effective contraception for up 7 months after completion of therapy, and non-sterile male participants must agree to use a condom for up to 7 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and hormonal therapy. EXCLUSION CRITERIA (Cohort 6 only) 1. Systemic autoimmune disease currently requiring treatment (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The participant must have been off treatment for 180 days. 2. History of organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted. 3. History of known active hepatitis B or C infection. 4. Active infection requiring antibiotic therapy. 5. History of or active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). 6. Had major surgery within 28 days prior to study enrollment. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating Investigator. 7. Inadequate organ function, evidenced by the following laboratory results: 1. Absolute lymphocyte count \< institutional ULN. 2. Absolute neutrophil count (ANC) \< 1,500 cells/mm3. 3. Platelet count \< 100,000 cells/mm3. 4. Total bilirubin greater than the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome). 5. Aspartate aminotransferase (AST \[SGOT\]) or ALT (SGPT) \> 1.5 × ULN. 6. Alkaline phosphatase (ALP) levels \> 2.5 × ULN. 7. Hemoglobin \< 9.0 g/dL. 8. Serum creatinine \> 2.0 mg/dL or 177 μmol/L or creatinine clearance \< 40 mL/min (using the Cockcroft-Gault formula below): Female = \[(140 - age in years) × weight in kg × 0.85\] / \[72 × serum creatinine in mg/dL\] Male = \[(140 - age in years) × weight in kg × 1.00\] / \[72 × serum creatinine in mg/dL\] 8. Have any of following: 1. Cirrhosis at a level of Child-Pugh B (or worse); 2. Cirrhosis (any degree) and a history of hepatic encephalopathy; or 3. Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis. 9. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. 10. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 11. Pregnant and nursing women.
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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
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Alaska Clinical Research Center
Anchorage, Alaska, 99530, United States
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Baptist Health - Lexington
Lexington, Kentucky, 40503, United States
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Baptist Health- Louisville
Louisville, Kentucky, 40207, United States
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Bon Secours Richmond
Richmond, Virginia, 23114, United States
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Chan Soon-Shiong Institute for Medicine
El Segundo, California, 90245, United States
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Cleveland Clinic - Main Site
Cleveland, Ohio, 44195, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
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Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270, United States
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Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
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Gettysburg/Hanover Cancer Centers
Gettysburg, Pennsylvania, 17325, United States
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Glendale Adventist Medical Center
Glendale, California, 91206, United States
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Henry Ford Hospital
Detroit, Michigan, 48202, United States
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Horizon Oncology Associates
Lafayette, Indiana, 47905, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Memorial Healthcare System
Hollywood, Florida, 33021, United States
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MemorialCare Health System
Fountain Valley, California, 37846, United States
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Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center
Springfield, Missouri, 65804, United States
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Mercy Clinic Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
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Mercy Research Joplin
Joplin, Missouri, 64804, United States
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Miami Cancer Institute (Baptist Health South Florida)
Miami, Florida, 33176, United States
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Oncology Consultants of Houston
Houston, Texas, 77024, United States
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Providence Portland Medical Center
Portland, Oregon, 97213, United States
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Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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Sanford Clinical Research
Sioux Falls, South Dakota, 57104, United States
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Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
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St. Francis Cancer Center/Bon Secours St. Francis Health System
Greenville, South Carolina, 29607, United States
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St. Vincent Frontier Cancer Center (SCL)
Billings, Montana, 59102, United States
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University of Iowa Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
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University of Miami
Miami, Florida, 33180, United States
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University of Minnesota - Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
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University of Rochester
Rochester, New York, 14642, United States
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University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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