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Ongoing Clinical Trials for Pancreatic Carcinoma Metastatic

This article provides detailed information about 26 ongoing clinical trials investigating new treatments for pancreatic carcinoma metastatic (also known as metastatic pancreatic cancer). These trials are being conducted across multiple countries in Europe and involve various therapeutic approaches including immunotherapy, targeted therapy, chemotherapy combinations, and innovative treatment methods.

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Evaluation of Hydrocortisone, Octreotide, and Teres Ligament Patch Combination to Prevent Complications After Pancreatoduodenectomy in Patients with Pancreatic Head Cancer or IPMN

This trial is investigating a comprehensive approach to reducing complications following pancreatoduodenectomy, a complex surgical procedure for pancreatic head cancer. The study focuses on patients with small pancreatic ducts (3mm or less), who face higher risk of post-surgical complications.

Main inclusion criteria: Patients must be at least 18 years old and scheduled for elective pancreatoduodenectomy due to pancreatic head carcinoma or intraductal papillary mucinous neoplasms. A key requirement is having a pancreatic duct diameter of 3mm or less on preoperative imaging.

Main exclusion criteria: Patients with allergies to the study medications, active infections, poorly controlled diabetes, pregnancy or breastfeeding, severe liver or kidney disease, chronic pancreatitis, recent participation in other trials, or use of certain interfering medications cannot participate.

Study focus: The trial tests a combination treatment bundle called HOP, consisting of hydrocortisone (anti-inflammatory steroid), octreotide (reduces pancreatic secretions), and teres ligament patch (tissue reinforcement). The primary goal is to determine whether this bundle reduces major complications after surgery, including pancreatic fistula, delayed gastric emptying, bleeding, and other potential issues. Patients are randomly assigned to receive either the HOP bundle or standard care.

Investigational treatments: The study uses three components: hydrocortisone to reduce inflammation, octreotide to decrease pancreatic enzyme production, and teres ligament patch to reinforce surgical connections and prevent leakage.

Study for Patients with BRCA Mutated Ovarian, Breast, Pancreatic, Prostate, and Endometrial Cancers Continuing Olaparib Treatment

This continuation study provides ongoing access to olaparib for patients who have completed previous oncology trials and continue to benefit from the treatment. The study includes patients with various BRCA-mutated cancers, including metastatic pancreatic cancer.

Main inclusion criteria: Patients must have completed a previous olaparib study and be judged by their doctor to still be benefiting from treatment. They must provide written consent and have appropriate cancer types, including gBRCA mutated metastatic pancreatic cancer.

Main exclusion criteria: The trial excludes patients who do not have BRCA gene mutations, those without the specified cancer types, patients outside the study age range, and those considered part of vulnerable populations.

Study focus: The primary objective is to ensure continuous, safe treatment while monitoring tolerability. The study tracks serious adverse events and quality of life, aiming to maintain disease control for patients who have already shown positive responses to olaparib.

Investigational treatment: Olaparib is a PARP inhibitor that prevents cancer cells from repairing their DNA. By blocking the PARP enzyme, it causes cancer cells with BRCA mutations to die, as they cannot repair the DNA damage that accumulates.

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This early-phase trial evaluates a new medication called DS-3939a for patients with advanced solid tumors that have not responded to standard treatments. The study includes patients with various cancers, including metastatic pancreatic cancer.

Main inclusion criteria: Patients must sign informed consent, be at least 18 years old, have adequate heart function (left ventricular ejection fraction ≥50%), good organ function, and measurable disease. They should have an ECOG performance status of 0-1 and confirmed diagnosis of locally advanced, metastatic, or unresectable cancer in organs including the pancreas.

Main exclusion criteria: The trial excludes patients with metastatic solid tumors outside the specified cancer types, those not meeting age requirements, vulnerable populations, and those who cannot tolerate the study drug.

Study focus: The trial is divided into two parts. Part 1 focuses on safety and tolerability, determining the appropriate dose. Part 2 evaluates effectiveness, measuring how well the treatment shrinks or controls tumors. Patients receive DS-3939a intravenously with regular monitoring.

Investigational treatment: DS-3939a is an experimental medication targeting specific cancer cell pathways. While the exact mechanism is under investigation, it aims to slow tumor growth by disrupting cancer cell functions.

Study of Ginisortamab with Nab-Paclitaxel and Gemcitabine or MEK Inhibitor for Patients with Metastatic Pancreatic Cancer

This trial explores ginisortamab, a new protein-based drug, combined with standard chemotherapy for metastatic pancreatic ductal adenocarcinoma. The study has two phases: initial treatment with chemotherapy and maintenance therapy for responders.

Main inclusion criteria: Patients must provide written consent, have confirmed metastatic pancreatic ductal adenocarcinoma, agree to provide tumor samples, have at least one measurable tumor, demonstrate ECOG performance status 0-1, maintain good blood and organ function, and be at least 18 years old.

Main exclusion criteria: Patients with other metastatic cancers, recent chemotherapy or radiotherapy (within 4 weeks), severe heart problems, uncontrolled infections, pregnancy or breastfeeding, known drug allergies, severe allergic reaction history, blood disorders, severe liver or kidney disease, recent investigational drug use, or substance abuse history cannot participate.

Study focus: Phase one combines ginisortamab with nab-paclitaxel and gemcitabine chemotherapy. Phase two offers ginisortamab with a MEK inhibitor as maintenance therapy for patients showing positive responses after at least 16 weeks. The study evaluates safety, tolerability, and anti-cancer effects.

Investigational treatments: Ginisortamab is a targeted therapy designed to attack specific cancer cells. Nab-paclitaxel and gemcitabine are standard chemotherapy drugs that stop cancer cell growth. MEK inhibitors block proteins helping cancer cells grow, used for maintenance therapy.

Study of RMC-6236 compared to standard therapy in previously treated metastatic pancreatic ductal adenocarcinoma

This randomized trial compares a new oral medication, RMC-6236, against standard treatment options for patients whose metastatic pancreatic cancer did not respond to initial chemotherapy. The study specifically targets tumors with RAS mutations.

Main inclusion criteria: Patients must be at least 18 years old with confirmed metastatic pancreatic cancer, ECOG performance status 0-1, adequate organ function, measurable disease, documented RAS mutation status, one previous treatment for metastatic disease, and ability to take oral medications.

Main exclusion criteria: The trial excludes patients with active brain metastases, recent other cancers (within 3 years), significant heart conditions, active autoimmune diseases, HIV or active hepatitis infections, serious medical conditions, pregnancy or breastfeeding, recent trial participation, known allergies, inability to swallow medications, or mental conditions affecting consent or compliance.

Study focus: Patients are randomly assigned to receive either RMC-6236 or standard chemotherapy combinations. Regular monitoring assesses treatment response through imaging and laboratory tests. The study measures overall survival and progression-free survival.

Investigational treatment: RMC-6236 specifically targets RAS G12 mutations commonly found in pancreatic cancer, offering a novel therapeutic approach for patients who have exhausted other options.

Study on Durvalumab and Rintatolimod for Patients with Metastatic Pancreatic Cancer

This trial evaluates combining durvalumab (an immune checkpoint inhibitor) with rintatolimod (a TLR-3 agonist) for patients with metastatic pancreatic cancer who have stable disease after FOLFIRINOX chemotherapy.

Main inclusion criteria: Patients must have metastatic pancreatic cancer, adequate kidney, liver, and bone marrow function, use effective contraception, have life expectancy of at least 12 weeks, provide written consent, have stable disease after at least 8 cycles of FOLFIRINOX, join within 6 weeks of stopping FOLFIRINOX, have an accessible metastatic lesion for biopsy, Systemic Immune-Inflammation Index less than 900, CA 19.9 level less than 1000 kU/L, be 18-75 years old, weigh over 30 kg, and have WHO performance status 0-2.

Main exclusion criteria: Patients with other cancers, different previous cancers (unless treated successfully for at least 5 years), serious heart problems, uncontrolled high blood pressure, active infections, pregnancy or breastfeeding, organ transplant history, certain interfering medications, recent clinical trial participation, chronic pancreatitis, or substance abuse history cannot participate.

Study focus: The study has two phases: phase Ib assesses safety for 6 weeks after first treatment, and phase II evaluates clinical benefit at 6 months. The trial monitors overall survival, progression-free survival, and quality of life throughout treatment.

Investigational treatments: Durvalumab helps the immune system recognize and attack cancer cells by blocking the PD-L1 protein. Rintatolimod stimulates the immune system through TLR-3 activation, enhancing the body’s ability to fight cancer.

Study on Napabucasin, Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer After Chemotherapy Failure

This trial compares napabucasin combined with paclitaxel and gemcitabine against standard chemotherapy for patients whose metastatic pancreatic cancer did not respond to gemcitabine-based treatment.

Main inclusion criteria: Patients must provide written consent, have adequate blood counts (neutrophils ≥1.5×10⁹/L, platelets ≥100,000/mm³, hemoglobin ≥9g/dL), proper blood chemistry levels (liver enzymes ≤2.5x normal or ≤5x with liver metastases, bilirubin ≤1.5x normal, creatinine within normal or GFR >60mL/min), normal blood clotting, normal urine tests, BMI ≥18 kg/m² with weight ≥40kg and albumin ≥3g/dL, stable pain symptoms, provide tumor tissue if available, be available for follow-up, have confirmed advanced pancreatic cancer, tried at least one previous chemotherapy, have measurable tumors, ECOG performance status 0-1, life expectancy over 12 weeks, be at least 18 years old, and use effective birth control.

Main exclusion criteria: The trial excludes patients without confirmed metastatic pancreatic cancer, those who haven’t experienced chemotherapy failure, patients outside the specified age range, and vulnerable populations.

Study focus: The trial has two phases. Phase I focuses on safety and progression-free survival. Phase II evaluates overall survival, comparing the new combination with standard treatment. Patients are randomly assigned to treatment groups with regular monitoring.

Investigational treatments: Napabucasin targets cancer stem cells and disrupts signaling pathways. Paclitaxel interferes with cancer cell division weekly. Gemcitabine is given in low doses to enhance treatment effectiveness.

Study on the Effectiveness of Paclitaxel and Gemcitabine for Patients with Pancreatic Cancer Spread to the Abdomen

This trial tests nabpaclitaxel and gemcitabine combination for pancreatic cancer with peritoneal metastases, using both systemic treatment and pressurized aerosol delivery directly into the abdomen.

Main inclusion criteria: Patients must be at least 18 years old, have adequate bone marrow function (neutrophils ≥1500/mm³, platelets ≥100,000/mm³), hemoglobin ≥9g/dl, adequate kidney function, mild or no side effects from previous treatments (except hair loss or mild neuropathy), liver enzymes within acceptable ranges, normal or slightly elevated bilirubin, provide informed consent, have confirmed pancreatic cancer with peritoneal spread, measurable disease, ECOG performance status 0-1, life expectancy of at least 3 months, no contraindications to laparoscopy or study drugs.

Main exclusion criteria: The trial excludes patients without pancreatic cancer with peritoneal metastases, those outside the specified age range, and vulnerable populations.

Study focus: The study evaluates disease control rate through combined treatment of systemic chemotherapy with three PIPAC (pressurized intraperitoneal aerosol chemotherapy) cycles. Patients undergo six cycles of systemic chemotherapy alongside three PIPAC treatments, with regular evaluations after each cycle.

Investigational treatments: Nabpaclitaxel stops cancer cells from dividing, delivered both systemically and as pressurized aerosol into the abdomen. Gemcitabine interferes with cancer cell DNA, used alongside nabpaclitaxel systemically.

Study on Valproic Acid, Simvastatin, and Gemcitabine for Untreated Metastatic Pancreatic Cancer Patients

This randomized trial tests whether adding valproic acid and simvastatin to standard gemcitabine and nab-paclitaxel chemotherapy improves outcomes for previously untreated metastatic pancreatic cancer patients.

Main inclusion criteria: Patients must provide signed consent, have confirmed metastatic pancreatic ductal adenocarcinoma, no previous treatments for mPDAC, ECOG performance status 0-1, measurable disease by RECIST 1.1 criteria, be at least 18 years old, have known DPD activity (for PAXG group), adequate bone marrow function (neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9g/dL), adequate liver function (bilirubin ≤1.5x normal or ≤2x with biliary stent, AST/ALT ≤5x normal), and adequate kidney function (creatinine ≤1.5mg/dL or clearance ≥60mL/min for males, ≥50mL/min for females).

Main exclusion criteria: The trial excludes patients with other cancer types, those outside specified age ranges, patients unable to follow procedures or take medications, those with serious interfering health conditions, pregnant or breastfeeding women, those in other trials, recent major surgery, allergies to study drugs, and substance abuse history.

Study focus: Patients are randomly assigned to receive either standard chemotherapy (gemcitabine plus nab-paclitaxel) or the same chemotherapy plus valproic acid and simvastatin. The study monitors progression-free survival, overall survival, tumor response, quality of life, and biomarkers predicting treatment response.

Investigational treatments: Valproic acid, typically used for seizures, is tested for enhancing cancer treatment. Simvastatin, usually for cholesterol, is explored for anti-cancer properties. Gemcitabine and nab-paclitaxel are standard chemotherapy drugs stopping cancer cell growth.

Study of M9140 for Patients With Advanced Pancreatic Cancer

This trial evaluates M9140, an antibody-drug conjugate targeting CEACAM5, for patients with advanced pancreatic cancer that hasn’t responded to previous treatments.

Main inclusion criteria: Patients must sign informed consent, have ECOG performance status 0-1, normal blood/liver/kidney function, at least one measurable tumor by RECIST v1.1, confirmed advanced or metastatic pancreatic ductal adenocarcinoma unresponsive to previous treatments, have tried 1-2 different treatments showing disease progression, have tumors with high CEACAM5 protein levels, be any gender, and can include vulnerable populations.

Main exclusion criteria: The trial excludes patients with other cancer types, those outside age ranges, patients unable to follow procedures, pregnant or breastfeeding women, severe uncontrolled medical conditions, recent cancer treatments, known medication allergies, vulnerable populations unable to consent.

Study focus: The study assesses M9140’s ability to shrink tumors or slow cancer growth when used alone. Regular monitoring through imaging and laboratory tests tracks cancer response and treatment tolerability. The trial evaluates objective response, duration of response, and disease control.

Investigational treatment: M9140 combines an antibody targeting CEACAM5 protein on cancer cells with a toxic drug, delivering treatment directly to cancer cells while minimizing effects on healthy tissue.

Study on Chemotherapy with Liposomal Irinotecan, Oxaliplatin, and 5-Fluorouracil for Patients with Pancreatic Cancer Spread to the Liver

This trial tests neoadjuvant chemotherapy with liposomal irinotecan, oxaliplatin, and 5-fluorouracil/leucovorin before surgery for patients with pancreatic cancer that has spread to the liver in limited spots.

Main inclusion criteria: Patients must have confirmed pancreatic cancer spread to liver (1-5 spots that can be treated), measurable disease by RECIST v1.1, ECOG performance status 0-1, adequate kidney function (creatinine clearance ≥60mL/min), adequate liver function (bilirubin ≤2mg/dL, liver enzymes ≤5x normal), adequate bone marrow function (neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9g/dL), normal blood clotting, be at least 18 years old, use effective birth control, provide written consent, and be legally capable of consent.

Main exclusion criteria: The trial excludes patients with different cancers, liver metastases in more than a few locations, previous disallowed treatments, serious interfering health conditions, inability to follow procedures or attend visits, pregnancy or breastfeeding, unwillingness to use birth control, recent trial participation, medication allergies, organ transplant history, and substance abuse history.

Study focus: Patients receive chemotherapy before surgery aiming to shrink tumors for complete removal (R0/R1 resection). The study monitors response, safety, and post-surgical recovery, tracking complications and long-term outcomes.

Investigational treatments: Liposomal irinotecan improves drug effectiveness and reduces side effects. Oxaliplatin damages cancer cell DNA. 5-fluorouracil interferes with cancer cell growth. Leucovorin enhances 5-fluorouracil’s effectiveness.

Summary

These 10 clinical trials represent diverse therapeutic approaches for metastatic pancreatic cancer, conducted across multiple European countries with France, Spain, Germany, and Italy showing the highest concentration of trials.

The studies range from surgical complication prevention to advanced systemic therapies. Notable patterns include strong focus on combination approaches, particularly immunotherapy with chemotherapy, and investigation of novel targeted agents like RMC-6236 and ginisortamab. Several trials specifically target patients who have failed initial treatments, addressing an important unmet need.

Geographical distribution shows France leading with representation in 10 trials, followed by Spain with 9 trials, and Germany with 7 trials. This concentration suggests these countries have established research infrastructure and patient populations for pancreatic cancer studies. The inclusion of vulnerable populations in some trials and careful exclusion criteria across all studies demonstrate attention to patient safety while maximizing potential benefit.

Common investigational approaches include PARP inhibitors for BRCA-mutated cancers, immune checkpoint inhibitors combined with chemotherapy, antibody-drug conjugates, and novel delivery methods like pressurized intraperitoneal aerosol chemotherapy. Many trials incorporate biomarker-driven patient selection, reflecting the move toward personalized medicine in pancreatic cancer treatment.

Ongoing Clinical Trials on Pancreatic carcinoma metastatic

  • Study on FOLFIRINOX, Pembrolizumab, and SABR for Patients with Borderline Resectable Pancreatic Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study Comparing Irinotecan, Fluorouracil, Folinic Acid, and Drug Combination for Patients with Metastatic Pancreatic Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Timing of Chemotherapy with Paclitaxel Albumin-Bound and Drug Combination for Patients with Metastatic Pancreatic Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of M9140 for Patients With Advanced Pancreatic Cancer

    Not yet recruiting

    1 1
    Investigated diseases:
    Austria France Germany Italy Spain

  • Study on Chemotherapy with Liposomal Irinotecan, Oxaliplatin, and 5-Fluorouracil for Patients with Pancreatic Cancer Spread to the Liver

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Irinotecan with S1 or 5-Fluorouracil for Patients with Metastatic Pancreatic Cancer After Gemcitabine Treatment

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Italy The Netherlands Spain

  • Study on Napabucasin, Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer After Chemotherapy Failure

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

  • Study on Dostarlimab, Vitamin D3, and Drug Combination for Untreated Metastatic Pancreatic Cancer Patients

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain

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