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Radiation Therapy With Combination Immunotherapy for Relapsed/Refractory Metastatic Melanoma

NCT03297463 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-08-01

No results posted yet for this study

Summary

This is a Phase 1b/2 study designed to evaluate combination of the human T-cell cytokine Interleukin-2 (IL-2) and a checkpoint inhibitor Ipilimumab immediately following a course of hypofractionated palliative radiation therapy in the management of unresectable, relapsed/refractory metastatic melanoma.

Conditions

Interventions

DRUG

Interleukin-2 & Ipilimumab (P-Ib)

Phase Ib: \- Ipilimumab will be administered in a 3 + 3 dose escalation design. * The starting dose will be 0.3 mg/kg administered within 7 days of day 1 cycle 2 ALdesleukin (IL-2). * If dose limiting autoimmune toxicities (DLTs) are not observed, the next cohort will receive 1.5 mg/kg. * The final cohort will receive 3 mg/kg, in the event that cohort 2 does not exhibit DLTs. * In the event of excessive toxicity in cohort 1, then a -1 dose level of 0.1 mg/kg may be evaluated in subsequent cohorts. Cohort sizes will increase to 6 patients if 1 of 3 patients in a cohort experience a DLT. * Once the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) is declared, no staggering of enrollment is required for accrual.

DRUG

Interleukin-2 & Ipilimumab (P-II)

Phase II: \- Interleukin-2 \& Ipilimumab will be administered at the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D).

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Domingo-Musibay Evidio, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2020-02-01
Completion
2020-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03297463 on ClinicalTrials.gov