A Phase IB Study to Evaluate Alteration of the Microbiome to Enhance Response to Immunotherapy in Patients with Inoperable or Metastatic Melanoma

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Full Title

A Multicenter Phase 1b Randomized, Placebo-controlled, Blinded Study to Evaluate the Safety, Tolerability and Efficacy of Microbiome Study Intervention Administration in Combination with Anti-PD1 Therapy in Adult Patients with Unresectable or Metastatic Melanoma (WIRB)

Purpose

Immunotherapy drugs called checkpoint inhibitors have improved the treatment of many people with metastatic melanoma, but not all patients respond well to this therapy. Research has shown that the type and amount of bacteria in a person’s gut (the “microbiome”) may influence which patients respond to a checkpoint inhibitor. In this study, researchers want to see if they can change a patient’s microbiome with a study drug, if that study drug is safe, and if it is possible to increase the likelihood that a patient with inoperable or metastatic melanoma will respond to checkpoint inhibitor immunotherapy.

All patients in this study will receive the checkpoint inhibitor nivolumab. A week before beginning nivolumab therapy, patients will be randomly assigned to start treatment to alter the microbiome or to receive placebos (inactive medications). Three groups of patients will receive an antibiotic (vancomycin) and a microbiome study drug (either SER-401 or FMT), while the other two groups will receive placebos that look like the antibiotic and microbiome study drug. Vancomycin is used to prepare the patient’s gut microbiome to allow acceptance of the microbiome study drug. Nivolumab is given intravenously (by vein) and the antibiotic and microbiome drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic melanoma.
  • Prior treatment for melanoma is permitted but must have been completed 6 weeks or more before entering the study, such as treatment with a CTLA-4 inhibitor (ipilimumab) or a BRAF inhibitor (such as vemurafenib). Patients may not have received PD1-inhibitor therapy (the class of drugs to which nivolumab belongs) or treatment for advanced melanoma.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alexander Shoushtari at 646-888-4161.

Protocol

19-275

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Co-Investigators

Diseases