Treatment Clinical Trials for Gallbladder Cancer

Clinical trials are research studies that involve people. The clinical trials on this list are for gallbladder cancer treatment. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 25
  • Nivolumab and Ipilimumab in Treating Patients with Rare Tumors

    This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial enrolls participants for the following cohorts based on condition: 1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07 / 27 / 2018) 2. Epithelial tumors of major salivary glands (closed to accrual 03 / 20 / 2018) 3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual) 4. Undifferentiated carcinoma of gastrointestinal (GI) tract 5. Adenocarcinoma with variants of small intestine (closed to accrual 05 / 10 / 2018) 6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10 / 17 / 2018) 7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03 / 20 / 2018) 8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible 9. Intrahepatic cholangiocarcinoma (closed to accrual 03 / 20 / 2018) 10. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03 / 20 / 2018) 11. Sarcomatoid carcinoma of lung 12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma 13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03 / 30 / 2018) 14. Trophoblastic tumor: A) Choriocarcinoma (closed to accrual 04 / 15 / 2019) 15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual 04 / 15 / 2019) 16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non-seminomatous tumor C) Teratoma with malignant transformation (closed to accrual 3 / 15 / 2019) 17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 18. Squamous cell carcinoma variants of the genitourinary (GU) system 19. Spindle cell carcinoma of kidney, pelvis, ureter 20. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07 / 27 / 2018) 21. Odontogenic malignant tumors 22. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) 23. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12 / 19 / 2017) 24. Pheochromocytoma, malignant 25. Paraganglioma (closed to accrual 11 / 29 / 2018) 26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex 27. Desmoid tumors 28. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09 / 19 / 2018) 29. Malignant giant cell tumors 30. Chordoma (closed to accrual 11 / 29 / 2018) 31. Adrenal cortical tumors (closed to accrual 06 / 27 / 2018) 32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12 / 22 / 2017) 33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03 / 15 / 2019) 34. Adenoid cystic carcinoma (closed to accrual 02 / 06 / 2018) 35. Vulvar cancer 36. MetaPLASTIC carcinoma (of the breast) 37. Gastrointestinal stromal tumor (GIST) (closed to accrual 09 / 26 / 2018) 38. Perivascular epithelioid cell tumor (PEComa) 39. Apocrine tumors / extramammary Paget’s disease 40. Peritoneal mesothelioma 41. Basal cell carcinoma 42. Clear cell cervical cancer 43. Esthenioneuroblastoma 44. Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual) 45. Clear cell cervical endometrial cancer 46. Clear cell ovarian cancer 47. Gestational trophoblastic disease (GTD) 48. Gallbladder cancer 49. Small cell carcinoma of the ovary, hypercalcemic type 50. PD-L1 amplified tumors 51. Angiosarcoma 52. High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 53). Small cell lung cancer is not eligible 53. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)
    Location: 869 locations

  • Gemcitabine Hydrochloride and Cisplatin with or without Nab-Paclitaxel in Treating Patients with Newly Diagnosed Advanced Biliary Tract Cancers

    This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
    Location: 599 locations

  • Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab, CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma

    The study is being conducted to assess the safety and tolerability of (1) PEGPH20 in combination with CIS and GEM (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and atezolizumab (PEGCISGEMATEZO) compared with (3) cisplatin and gemcitabine (CISGEM).
    Location: 18 locations

  • Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158 / KEYNOTE-158)

    In this study, participants with multiple types of advanced (unresectable and / or metastatic) solid tumors that have progressed on standard of care therapy will be treated with pembrolizumab.
    Location: 10 locations

  • M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

    The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
    Location: 7 locations

  • A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer

    This study is to define the safety profile and to determine the Maximal tolerated dose regimen and preliminary efficacy of AbGn-107 administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic or biliary cancer.
    Location: 7 locations

  • Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080 / MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005 / E7080-G000-224 / LEAP-005)

    The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080 / MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), or biliary tract cancers (BTC). Participants will be enrolled into initial tumor-specific cohorts which will be expanded if adequate efficacy is determined.
    Location: 5 locations

  • Gemcitabine Hydrochloride, Cisplatin, and Nivolumab in Treating Participants with Muscle-Invasive Bladder Cancer

    This phase II trial studies the side effects of gemcitabine hydrochloride, cisplatin, and nivolumab and to see how well they work in treating participants with muscle-invasive bladder cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving gemcitabine hydrochloride, cisplatin, and nivolumab may work better in treating participants with muscle-invasive bladder cancer.
    Location: 8 locations

  • Guadecitabine and Durvalumab in Treating Patients with Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer

    This phase Ib trial studies the side effects and best dose of guadecitabine and how well it works when given together with durvalumab in treating patients with liver, pancreatic, bile duct, or gallbladder cancer that has spread to other places in the body. Guadecitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with durvalumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Giving guadecitabine and durvalumab may work better in treating patients with liver, pancreatic, bile duct, or gallbladder cancer.
    Location: 4 locations

  • Recombinant EphB4-HSA Fusion Protein with Standard Chemotherapy Regimens in Treating Patients with Advanced or Metastatic Solid Tumors

    This pilot phase Ib trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein when given together with standard chemotherapy regimens in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic). Drugs used in chemotherapy, such as recombinant EphB4-HSA fusion protein, paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, docetaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether standard chemotherapy regimens are more effective with recombinant ephB4-HSA fusion protein in treating advanced or metastatic solid tumors.
    Location: 4 locations

  • A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer

    A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem]) in patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy in the locally advanced or metastatic setting, and for which treatment with 1L therapy (defined as a combination of cis / gem) is planned.
    Location: 2 locations

  • Chemotherapy before and after Surgery in Treating Patients with Resectable Gallbladder Cancer

    This phase III trial studies how well chemotherapy before and after surgery works in treating patients with gallbladder cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin, gemcitabine hydrochloride, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery may kill more tumor cells.
    Location: 3 locations

  • CBP501, Cisplatin and Nivolumab in Advanced Refractory Tumors

    This is a multicenter, open-label, phase 1b study of CBP501 / cisplatin / nivolumab combination administered once every 21 days to patients with advanced solid tumors.
    Location: 2 locations

  • GL-ONC1 with or without Eculizumab in Treating Patients with Solid Organ Cancers before Surgery

    This phase Ib trial studies the side effects and best dose of light-emitting oncolytic vaccinia virus GL-ONC1 (GL-ONC1) when given with or without eculizumab in treating patients with solid organ cancers before surgery. A virus called GL-ONC1, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Monoclonal antibodies, such as eculizumab, may interfere with the ability of tumor cells to grow and spread. Giving GL-ONC1 with or without eculizumab may work better in treating patients with solid organ cancers.
    Location: 2 locations

  • Pembrolizumab and Sargramostim in Treating Patients with Advanced Bile Duct Cancer

    This phase II trial studies how well pembrolizumab and sargramostim work in treating patients with bile duct cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving pembrolizumab and sargramostim may work better in treating patients with bile duct cancer.
    Location: 2 locations

  • Personalized Cancer Therapy in Treating Participants with Metastatic or Unresectable Cancers

    This pilot trial studies how well personalized cancer therapy works in treating participants with cancer that has spread to other places in the body or cannot be removed by surgery. Personalized cancer therapy is the practice of making decisions about what kind of treatment participants should receive based on the genetic makeup of the tumor. Genes in your body encode certain characteristics such as height, eye and hair color. Researchers believe that abnormal genes in tumors may affect how individuals respond to cancer treatments. Collecting information about tests and treatments received will help researchers describe if patients respond better when their physicians choose to treat them according to the genetic makeup of their tumor.
    Location: 2 locations

  • Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer

    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 18-70 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. ...
    Location: 2 locations

  • Cell Therapy (Tumor Infiltrating Lymphocytes) and Aldesleukin in Treating Patients with Locally Advanced, Recurrent, Refractory, or Metastatic Biliary Tract Cancers

    This phase II trial studies how well tumor infiltrating lymphocytes and aldesleukin work in treating patients with biliary tract cancers that has spread to other places in the body, has come back, or does not respond to treatment. Tumor infiltrating lymphocytes are a type of white blood cells which are taken from patients' tumors, grown in the laboratory in large numbers, and then given back to the patient to fight the tumor. Before receiving the cells, chemotherapy drugs called cyclophosphamide and fludarabine are given to temporarily suppress the immune system to improve the chances that the tumor fighting cells will be able to survive in the body. After the cells are given, aldesleukin may help the tumor fighting cells stay alive longer. This study is being done to see if giving tumor infiltrating lymphocytes and aldesleukin will cause biliary tract tumors to shrink.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • Nivolumab, Nal-Irinotecan, Fluorouracil, and Leucovorin as Second Line Therapy in Treating Patients with Advanced Biliary Tract Cancer

    This phase Ib / II trial studies the side effects of nivolumab, nal-irinotecan, fluorouracil, and leucovorin and to see how well they work in treating patients with biliary tract cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as nal-irinotecan, 5-fluorouracil, and leucovorin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with chemotherapy (nal-irinotecan, 5-fluorouracil, and leucovorin) may work better in treating patients with biliary tract cancer compared to chemotherapy alone.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • Rucaparib and Nivolumab in Treating Patients with Advanced or Metastatic Biliary Tract Cancer after Platinum Therapy

    This phase II trial studies how well rucaparib and nivolumab work in treating patients with biliary tract cancer that has spread to other places in the body after platinum therapy. Rucaparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving rucaparib and nivolumab after platinum therapy may help kill more cancer cells that are left after chemotherapy.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)

    Background: Biliary tract cancers are rare but they are serious. Researchers want to see if a certain drug helps the immune system fight cancer cells. The drug is called pembrolizumab. It may work even better with two chemotherapy drugs that are widely used to treat gastrointestinal cancers. Objective: To study if pembrolizumab given with capecitabine and oxaliplatin (CAPOX) increases the time it takes for a person's biliary tract cancer to get worse. Eligibility: People age 18 and older with previously treated biliary tract cancer that has spread to other parts of the body Design: Participants will be screened with tests as part of their regular cancer care. Each study cycle is 3 weeks. For 6 cycles, participants will: Get pembrolizumab and oxaliplatin on day 1 of each cycle. They will be given in an intravenous (IV) catheter. Take capecitabine by mouth for 2 weeks then have 1 week without it. Participants will complete a patient diary. Starting with cycle 7, participants will get only pembrolizumab. They will get it once every 3 weeks. On day 1 of every cycle, participants will have: Physical exam Review of symptoms and how well they do normal activities Blood tests Every 9 weeks, they will have a scan. Participants may have tumor samples taken. Participants will have a final visit about 1 month after they stop the study drug. After that, they will be contacted by phone or email yearly. ...
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)

    BACKGROUND: - Various tumor ablative procedures and techniques have been shown to result in immunogenic cell death and induction of a peripheral immune response. The term ablative therapies applies to trans-arterial catheter chemoembolization (TACE), radiofrequency ablation (RFA) and cryoablation (CA). - The underlying hypothesis of this study is that the effect of immune checkpoint inhibition can be enhanced by TACE, CA and RFA in patients with advanced hepatocellular carcinoma (HCC) and biliary tract carcinomas (BTC). We have already demonstrated proof of principle as well as safety and feasibility of this approach with anti-CTLA4 therapy. - Based on the concept of PDL1-mediated adaptive resistance and the emerging role of PD1 therapy in HCC, we would like to evaluate the combination of tremelimumab and durvalumab (with ablative therapies) in HCC and BTC. Objectives: - To preliminarily evaluate the 6-month progression free survival (PFS) of combining tremelimumab and durvalumab in patients with advanced HCC (either alone or with cryoablation, TACE or RFA) and in patients with advanced biliary tract carcinoma (BTC) (either alone or with cryoablation or RFA). ELIGIBILITY: - Histologically or cytologically confirmed diagnosis of HCC or biliary tract carcinoma OR histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of HCC (or biliary tract carcinoma). - Childs-Pugh A / B7 cirrhosis only is allowed. If patient does not have cirrhosis, this limitation does not apply. - Patients must have disease that is not amenable to potentially curative resection, radiofrequency ablation, or liver transplantation. DESIGN: We will evaluate the combination of tremelimumab and durvalumab (with ablative therapies) in cohorts A (HCC; N=40) and B (BTC; N=30). The first N=10 patients in both cohorts will receive tremelimumab and durvalumab only (i.e. No interventional radiologic procedures). - A: Advanced HCC, BCLC# Stage B / C - N= 1st 10 pts: No ablative procedure Cryoablation / RFA / TACE## - Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28 days until EOS### - 40 total: 10 trem+ dur alone; 10 trem+ dur + TACE; 10 trem + dur + RFA; 10 trem + dur + cryo - B: Intra / extra-hepatic cholangiocarcinoma - N= 1st 10 pts: No ablative procedure; RFA / cryoablation - Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28 days until EOS### - 30 total: 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem - BCLC = Barcelona clinic liver cancer staging system - For BCLC stage B patients TACE may be repeated as per standard of care - EOS = End of study treatment or meeting any of the off-treatment or off study criteria.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Ramucirumab in Treating Patients with Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery

    This phase II trial studies how well ramucirumab works in treating patients with previously treated biliary cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Oncolytic HSV-1 rRp450 in Treating Patients with Primary Liver Cancer or Liver Metastases

    This phase I trial studies the side effects and best dose of oncolytic HSV-1 rRp450 in treating patients with primary liver cancer or cancer that has spread from the original tumor to the liver (liver metastases). A virus called herpes simplex virus (HSV)-1, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.
    Location: Massachusetts General Hospital Cancer Center, Boston, Massachusetts

  • Pembrolizumab (MK-3475) Plus Gemcitabine / Cisplatin Versus Placebo Plus Gemcitabine / Cisplatin for First-Line Advanced and / or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966 / KEYNOTE-966)

    This is a study of pembrolizumab plus gemcitabine / cisplatin versus placebo plus gemcitabine / cisplatin as first-line therapy in participants with advanced and / or unresectable biliary tract carcinoma. The study has 2 primary hypotheses: 1. Pembrolizumab plus gemcitabine / cisplatin is superior to placebo plus gemcitabine / cisplatin with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) and 2. Pembrolizumab plus gemcitabine / cisplatin is superior to placebo plus gemcitabine / cisplatin with respect to overall survival (OS).
    Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia