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Aldesleukin / Pembrolizumab (Keytruda) / Metastatic Pancreatic Cancer · Phase 2 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 trial registration for TIL-based immunotherapy in patients with metastatic solid tumors (colorectal, pancreatic, ovarian, breast, and endocrine cancers). No efficacy or safety results are reported in this registry record; the study is currently recruiting and results are not yet available.
Phase 2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Metastatic Ovarian Cancer, Metastatic Breast Carcinoma, Metastatic Endocrine Tumors/ Neuroendocrine…; age from 18 Years; to 72 Years. Intervention: 1/CD8+ Enriched TIL (CLOSED); 2/Unselected TIL (CLOSED); 3/Unselected TIL + Pembro Prior to Cells; 4/Unselected TIL + Pembro at POD; 5/Unselected TIL + Pembro Prior to Cells. n = 332. 1 site: United States.
This is a Phase 2 trial registration for TIL-based immunotherapy in patients with metastatic solid tumors (colorectal, pancreatic, ovarian, breast, and endocrine cancers). No efficacy or safety results are reported in this registry record; the study is currently recruiting and results are not yet available.
Efficacy and safety data not yet available
This trial will inform whether young TIL selected from tumors can induce responses in solid tumors beyond melanoma. No interim or final results are yet available to guide clinical practice.
This is a Phase 2 interventional trial registration with no results reported; the study is actively recruiting and has not yet yielded efficacy or safety data.
As stated by the source record.
Quoted from the source exactly as published.
This trial will inform whether young TIL selected from tumors can induce responses in solid tumors beyond melanoma. No interim or final results are yet available to guide clinical practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT01174121). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 332 participants (ESTIMATED). Conditions: Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Metastatic Ovarian Cancer, Metastatic Breast Carcinoma, Metastatic Endocrine Tumors/ Neuroendocrine Tumors. Interventions: DRUG: Pembrolizumab (Keytruda); DRUG: Fludarabine; DRUG: Cyclophosphamide; DRUG: Aldesleukin; BIOLOGICAL: Young TIL. Primary outcome measures: Response rate , 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per PI discretion. Brief summary: Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian/endometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian/endometrial tumors to shrink and to see if this treatment is safe. Eligibility: \- Adults age 18-72 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial cancer, or glioblastoma refractory to standard chemotherapy. Design: Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed. Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. (Leukapheresis is a common procedure, which removes only the white blood cells from the patient.) Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days. ...
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