Clinical Trial: NCT04581382 - My Cancer Genome

NCT04581382

Description:

This early phase I trial investigates how well radiation therapy, plasma exchange, and pembrolizumab or nivolumab work in treating patients with melanoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Plasma exchange (also known as "plasmapheresis") is a way to "clean" or "flush out" the blood. Immunotherapy with monoclonal antibodies, such as pembrolizumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Plasma exchange may help to improve the effect of standard radiation therapy and immunotherapy treatment on tumor cells of patients with melanoma.

Related Conditions:

Melanoma

Recruiting Status:

Recruiting

Phase:

Early Phase 1

URL:

https://clinicaltrials.gov/show/NCT04581382

Trial Eligibility

Document

Title

Brief Title: Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma
Official Title: Radiation Therapy, Plasma Exchange, and Immunotherapy in Melanoma

Clinical Trial IDs

ORG STUDY ID: MC200703
SECONDARY ID: NCI-2020-06970
SECONDARY ID: MC200703
SECONDARY ID: P30CA015083
NCT ID: NCT04581382

Conditions

Melanoma

Interventions

Drug	Synonyms	Arms
Nivolumab	BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo	Treatment (radiation therapy, plasma exchange, immunotherapy)
Pembrolizumab	Keytruda, Lambrolizumab, MK-3475, SCH 900475	Treatment (radiation therapy, plasma exchange, immunotherapy)
Therapeutic Exchange Plasma	TEP	Treatment (radiation therapy, plasma exchange, immunotherapy)

Purpose

Detailed Description

      PRIMARY OBJECTIVE:

      I. To determine the kinetics of soluble (s)PD-L1 removal and regeneration by plasma exchange
      in patients with melanoma.

      SECONDARY OBJECTIVES:

      I. To observe response at 3 months after plasma exchange plus immunotherapy. II. To observe
      ongoing response at approximate 3 month intervals after plasma exchange plus immunotherapy.

      CORRELATIVE RESEARCH OBJECTIVES:

      I. To determine the effects of plasma exchange on immune cell function. II. To observe the
      kinetics of extracellular vesicles (EVs) after plasma exchange in patients with melanoma.

      OUTLINE:

      Patients undergo radiation therapy daily on days 1-5 (weekdays). Patients then undergo
      therapeutic plasma exchange over 1-2 hours on days 4-6 or 5-7. Beginning on day 7, patients
      receive pembrolizumab intravenously (IV) or nivolumab IV. Treatment with pembrolizumab
      continues every 3 weeks or treatment with nivolumab continues every 2 weeks in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 3 weeks and then for up to 2
      years.

Trial Arms

Name	Type	Description	Interventions
Treatment (radiation therapy, plasma exchange, immunotherapy)	Experimental	Patients undergo radiation therapy daily on days 1-5 (weekdays). Patients then undergo therapeutic plasma exchange over 1-2 hours on days 4-6 or 5-7. Beginning on day 7, patients receive pembrolizumab IV or nivolumab IV. Treatment with pembrolizumab continues every 3 weeks or treatment with nivolumab continues every 2 weeks in the absence of disease progression or unacceptable toxicity.	Nivolumab Pembrolizumab Therapeutic Exchange Plasma

Eligibility Criteria

        Inclusion Criteria:

          -  Histological confirmation of melanoma. Patients may have completed biopsy outside of
             Mayo Clinic, but there must be an internal review done to confirm diagnosis prior to
             confirming eligibility

          -  Measurable or non-measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 3

          -  sPD-L1 levels > 1.7 ng/ml by enzyme-linked immunosorbent assay (ELISA)

          -  Feasible vascular access as determined by study apheresis technician

          -  Negative pregnancy test done =< 7 days prior to radiation therapy, for women of
             childbearing potential only

          -  Provide written informed consent

          -  Willing to return to enrolling institution for follow-up (during the Active Monitoring
             Phase of the study)

          -  Willing to provide blood samples for correlative research purposes

        Exclusion Criteria:

          -  Persons taking a biotin supplement

          -  sPD-L1 level < 1.7 ng/ml by ELISA

          -  Pregnant or nursing women

          -  Men or women of childbearing potential who are unwilling to employ adequate
             contraception

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Feasibility of treatment approach
Time Frame:	Up to 2 years
Safety Issue:
Description:	Feasibility will be assessed tracking of the accrual and accrual rate. This will be tracked by spreadsheet and being able to complete the study accrual in a reasonable time period.

Secondary Outcome Measures

Measure:	Overall response rate
Time Frame:	Up to 2 years
Safety Issue:
Description:	Overall response rate is the proportion of patients with a tumor response (partial response or complete response at least 4 weeks apart).

Measure:	Progression-free survival (PFS)
Time Frame:	From registration to the first of either disease progression or death from any cause, assessed up to 2 years
Safety Issue:
Description:	PFS will be estimated using the method of Kaplan-Meier.

Measure:	Overall survival (OS)
Time Frame:	From registration to death from any cause, assessed up to 2 years
Safety Issue:
Description:	OS will be estimated using the method of Kaplan-Meier.

Measure:	Incidence of adverse events (AEs)
Time Frame:	Up to 2 years
Safety Issue:
Description:	The descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be utilized for AE reporting. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.

Details

Phase:	Early Phase 1
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Mayo Clinic

Last Updated

June 21, 2021

Clinical Trials /

Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma