Pembrolizumab/Lenvatinib With and Without Healthy Donor FMT (hdFMT) in Relapsed/ Refractory (R/R)… (NCT06030037) | Clinical Trial Compass
WithdrawnPhase 2
Pembrolizumab/Lenvatinib With and Without Healthy Donor FMT (hdFMT) in Relapsed/ Refractory (R/R) Melanoma
Stopped: Trial withdrawn per PI directive
0Started 2025-03-11
Plain-language summary
In this is a randomized phase II study the addition of hd-FMT (healthy donor fecal-microbiota transplant) to pembrolizumab /lenvatinib in PD-1 R/R melanoma will be evaluated over a 104-week period in patients with anti-PD-1 R/R disease. Patients with PD-1 refractory advanced melanoma are eligible to enroll, excluding patients with prior lenvatinib (or other TKI) exposure. Intestinal microbiome composition mediates response to anti-PD-1 by affecting systemic inflammatory tone.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with cutaneous melanoma or unknown primary melanoma may enroll. Patients with uveal or mucosal or acral-lentiginous melanoma are excluded.
* Male participants:
• A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
* Female participants:
* A female participant is eligible to participate if she is not pregnant; not breastfeeding, and at least one of the following conditions applies:
* Not a woman of childbearing potential (WOCBP); OR
* A WOCBP who agrees to follow the contraceptive guidanceper protocol during the treatment period and for at least 120 days after the last dose of study treatment.
* Participants must have progressed on treatment with an anti-PD(L)1 ICI administered either as monotherapy or in combination with other checkpoint inhibitors or other standard/investigational therapies. PD-1 treatment progression is defined by meeting all the following criteria:
* Has received at least 2 doses of an approved anti-PD(L)1 ICI administered as a single agent, in combination with chemotherapy, and/or in combination with other investigational therapy.
* Participants who progressed on/within 3 months of adjuvant therapy with anti-PD(L)1 ICI will eligible.
* Demonstrated disease progression after anti-PD-1/L1 as defined by RECIST v1.1. The init…