| Title |
A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Patients With Advanced Melanoma |
| Protocole ID |
ME17 (Canbiome2) |
| ClinicalTrials.gov ID |
NCT06623461 |
| Cancer Type(s) |
Melanoma |
| Phase |
Phase II |
| Stage |
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| Study Type |
Treatment |
| Drug |
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| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
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| City |
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| Principal Investigator |
Dr. Rahima Jamal
|
| Coordinator |
Adeline Hamon
514-890-8000 poste 30737
|
| Status |
Recruiting |
| Activation Date |
22-01-2025 |
| Eligibility Criteria |
- Participants must have a confirmed histological diagnosis of cutaneous melanoma or melanoma of unknown primary.
- Participants must have stage IV or advanced unresectable disease.
- No prior ICB treatment for advanced unresectable or metastatic disease. Participants may have received adjuvant or neoadjuvant ICB if last dose was given ≥ 6 months prior to enrollment
- Prior targeted therapy with BRAF/MEK inhibition in the adjuvant or advanced / metastatic setting is permitted if at least 2 weeks have elapsed between the last dose and study enrollment. Participants must have recovered to ≤ grade 1 from all toxicity related to BRAF/MEK inhibition
- Prior radiation therapy is permitted if at least 7 days have elapsed between the last fraction and study enrollment. Participants must have recovered to ≤ grade 1 from all toxicity related to prior radiotherapy.
- Previous major surgery is permitted provided that surgery occurred ≥ 14 days prior to participant enrollment and that wound healing has occurred.
- Participants must have measurable disease as per RECIST 1.1/ iRECIST.
- Participants must be at least 18 years of age.
- Participants must have an ECOG performance status of 0, 1, or 2.
- The participant's standard-of-care ICB regimen must be selected prior to enrollment and must stay the same, regardless of arm assignment, post-enrollment
- Participants must demonstrate adequate organ function Participants must be able to ingest capsules.
- Participants must consent to provision of samples of blood and stool for correlative marker analysis.
- Participants must consent to provision of, and investigator must agree to submit, a representative archival formalin fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available.
- Participants must have access to provincially-funded standard-of-care ICB treatment.
- Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.
- Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- Protocol ICB treatment must begin within 14 calendar days after participant enrollment.
- Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
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| Exclusion Criteria |
- Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Participants who have received antibiotics within 14 days of enrollment.
- Participants with systemic corticosteroid use > 10mg per day.
- Participants with concurrent treatment with other anti-cancer therapy.
- Participants that have received live attenuated vaccination administered within 30 days prior to randomization. Note: Seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and not allowed.
- For participants with history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Participants with absolute contraindications to FMT including: a) Toxic megacolon; b) Inflammatory bowel disease; c) Severe dietary allergies
- Participants with hypersensitivity to PegLyte®
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Participants with symptomatic brain metastases unless brain lesions are shown to be stable, according to the following definitions:
- without evidence of progression for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases; or
- treated with surgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases; or
- treated with stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.
- Participants with leptomeningeal disease.
- Participants with any uncontrolled autoimmune disease that requires active immunosuppressive agents.
- Participants who are solid organ transplantation recipients.
- Participants living with HIV.
- Participants with active infection. Participants may be eligible following recovery. Participants requiring antibiotics require 2-week washout period prior to enrollment.
- Participants that are pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
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Groupe d'étude en oncologie du Québec