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New treatment option for Advanced Biliary Tract Carcinoma
Official title MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
ClinicalTrials.gov ID: NCT07036380
What this study is testing
What is MP0317 + Gemcitabine + Cisplatine + Durvalumab?
MP0317 + Gemcitabine + Cisplatine + Durvalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced biliary tract carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In the present TACTIC clinical trial, the investigators propose to determine the clinical interest and immunological efficacy of a treatment combining MP0317 the FAP (Fibroblast Activation Protein)-dependent CD40 agonist, with anti-PD-L1(Programmed Death-Ligand 1) therapy (durvalumab) and gemcitabine-cisplatin-based chemotherapy in unresectable cholangiocarcinoma. The main objective is to assess the 12-month progression free survival (PFS) rate in the experimental arm.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated informed consent
- Histologically confirmed biliary tract carcinoma: intra/extrahepatic cholangiocarcinoma (note that gallbladder carcinoma are not eligible)
- Locally advanced unresectable or metastatic
- Patient who had not previously received systemic anti-cancer treatment (adjuvant treatment with Capecitabine is allowed if the end of the...
- Age ≥ 18 years
You likely can't join if
- For patients whose tumors present a genetic alteration of IDH1, FGFR2 or BRAF as well as an amplification of HER2, the investigators of the TACTIC...
- Patients previously exposed to anti-tumor immunotherapy such as anti-PD-1, anti-PD-L1, or anti-CTLA4 (cytotoxic T-lymphocyte-associated protein 4)...
- Diagnosis of additional malignancy within 3 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin...
- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
- Current participation in a study of an investigational agent or in the period of exclusion
- Patient under guardianship, curatorship or under the protection of justice
See the full eligibility criteria
Who can join
- Signed and dated informed consent
- Histologically confirmed biliary tract carcinoma: intra/extrahepatic cholangiocarcinoma (note that gallbladder carcinoma are not eligible)
- Locally advanced unresectable or metastatic
- Patient who had not previously received systemic anti-cancer treatment (adjuvant treatment with Capecitabine is allowed if the end of the chemotherapy was at least 6 months ago)
- Age ≥ 18 years
- Measurable disease defined according to RECIST v1.1 (Response Evaluation Criteria In Solid Tumours) guidelines Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has...
- Patients who have received previous chemoembolization, radioembolization and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 according to National Cancer Institute...
- Performance status ECOG-PS \< 2 (Eastern Cooperative Oncology Group)
- Females must be using highly effective contraceptive measures, and have a negative pregnancy test prior to the start of dosing if of childbearing potential, and during treatment and at least 7 months after the end of...
- Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
- Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle...
- Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and at least: 4 months after the end of the treatment with cisplatin and 3 months after the...
- Documented virology status of hepatitis, as confirmed by screening HBV and HCV tests:
- For patients with active HBV: HBV DNA \<500 IU/ml (International unit)during screening, initiation of anti-HBV treatment at least 14 days prior to randomization and willingness to continue anti-HBV treatment during the...
- Patients with HCV, either with resolved infection (as evidenced by detectable antibody) or chronic infection (as evidence by detectable HCV RNA), are eligible
- Patient affiliated to or beneficiary of French social security system
- Ability to comply with the study protocol, in the Investigator's judgment.
What rules you out
- For patients whose tumors present a genetic alteration of IDH1, FGFR2 or BRAF as well as an amplification of HER2, the investigators of the TACTIC study recommend, if possible, the orientation for preferential inclusion...
- Patients previously exposed to anti-tumor immunotherapy such as anti-PD-1, anti-PD-L1, or anti-CTLA4 (cytotoxic T-lymphocyte-associated protein 4) agent or any immune therapy
- Diagnosis of additional malignancy within 3 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer
- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
- Current participation in a study of an investigational agent or in the period of exclusion
- Patient under guardianship, curatorship or under the protection of justice
- Other liver malignancy: hepatocellular carcinoma and hepato-cholangiocarcinoma
- Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
- Uncontrolled tumor-related pain: exposing patients to risk of exposure to corticoids or iterative hospitalizations. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to inclusion. Patients...
- Known active central nervous system metastases and/or carcinomatous meningitis.
- History of angiocholitis, liver abscess, or acute pancreatitis within 4 weeks prior to initiation of study treatment
- Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition. Patients requiring oxygen therapy or with LEVF\<40% (Left...
- HIV (human immunodeficiency virus) positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus
- Any immunosuppressive therapy (i.e. corticosteroids \>10 mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy
- Active autoimmune disease that has required a systemic treatment in the past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed. Active or history of...
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following...
- Rash must cover \< 10% of body surface area,
- Disease is well controlled at baseline and requires only low-potency topical corticosteroids,
- No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral...
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of durvalumab
- Receipt of a live, attenuated vaccine within 30 days prior to inclusion or anticipation that such a live, attenuated vaccine will be required during the study Note: Patients must agree not to receive live, attenuated...
- Inadequate hematology function: Lymphocyte count at baseline \< 700/mm3; neutrophil count \< 1 500/mm3, platelets \< 10 0000/mm3 (without transfusion), Hemoglobin \< 9g/dL (patients may be transfused to meet this...
- Inadequate hepatic function: bilirubin \>2 fold ULN (upper limit of normal), AST/ALT \>3 fold ULN, International normalized thromboplastin time ratio \>2
- Creatinine clearance (CrCl) \< 60 ml/min (by the Modification of Diet in Renal Disease [MDRD], Cockroft formula, or chronic kidney disease [CKD] formula])
- Serum albumin \< 28 g/L
- Surgery within 4 weeks previously the initiation of the study treatment
- Radiotherapy within 2 weeks previously the initiation of the study treatment
- Patient with weight \< 36 kg.
- Pregnant or breastfeeding woman
- Known hypersensitivity to components of MP0317, for exemple, histidine buffer or the Tween diluent, according to section 7.2 " Contraindications " of the Investigator's brochure of MP0317
- Hypersensitivity to gemcitabine or to cisplatin, or to any of their excipients, according to the SmPCs of these products
- According to the SmPC of cisplatin: hearing problem, in case of combination with phenytoin with prophylactic aim, patients with neuropathy caused by cisplatin, in case of cardiorespiratory pathology in particular, which...
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Dijon, France
- Grenoble, France
- Lyon, France
- Montpellier, France
- Paris, France
- Rennes, France
- Tours, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Dijon, France; Grenoble, France; Lyon, France; Montpellier, France; Paris, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.