Anti-PD-1 Antibody With HD IL-2 in Metastatic Melanoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

May 7, 2018

Primary Completion Date

October 16, 2019

Study Completion Date

October 16, 2019

Conditions
Melanoma
Interventions
DRUG

Pembrolizumab

Subjects will receive 200 mg pembrolizumab every 3 weeks for two cycles. Cycle length is 21 days (i.e., 3 weeks). On the last day of Cycle 2 (+/- 3 days), disease status will be assessed via imaging.

DRUG

Interleukin-2

Following the pembrolizumab treatment, HD IL-2 treatment will commence. After completing the 2 cycles of pembrolizumab, High Dose Interleukin-2 (HD IL-2) will be administered. This will require a hospital stay of at least 5 days for each treatment cycle. Established guidelines will be followed for safely administering HD-IL-2 and managing toxicities from this treatment. Two treatment cycles will be administered, Cycle 2 being separated from Cycle 1 by approximately 9 days after completion (assuming subject has recovered from Cycle 1 adequately to proceed with Cycle 2). Four weeks after completion of the 2 cycles (called a course of HD IL-2 therapy), disease status will be monitored via CT of the chest and abdomen/pelvis using revised RECIST guidelines

Trial Locations (1)

68114

Nebraska Cancer Specialists, Omaha

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Nebraska Cancer Specialists Methodist Estabrook Cancer Center

OTHER

collaborator

Prometheus Laboratories

INDUSTRY

lead

Ralph Hauke

OTHER