UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade

Part of paid clinical trials in Sacramento, California.

Sponsor
Megan Daly, MD
Study ID
NCT03474497
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IL-2 — DRUG
    • A total of four interleukin-2 treatments will be delivered into the treatment lesion by intralesional injection biweekly (at least 48 hours apart) starting 24-96 hours after the completion of radiotherapy and to be completed during the second on-trial cycle of Pembrolizumab. Intralesional injections will be performed by direct visualization and/or palpation of the lesion or under ultrasound or CT guidance as indicated.
  • Pembrolizumab — DRUG
    Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol.
  • Radiotherapy — RADIATION
    Radiotherapy will be delivered to the treatment lesion during the second cycle of therapy using an 8 Gy x 3 fractions palliative regimen. Fractions may be delivered on consecutive or every other day but must be completed during week 1-2 of cycle 2 and will not be repeated in future cycles.

Study Details

This is a phase I/II study that will evaluate the safety and toxicity of this combinatorial approach. Eligible patients \>18 years of age with histologically proven metastatic NSCLC, melanoma, RCC, or HNSCC who have failed PD-1 / PD-L1 checkpoint blockade therapy will be enrolled. Patients must have a candidate treatment lesion (subcutaneous, nodal, or visceral) accessible and safe for radiotherapy and serial intralesional injections as specified by the protocol. They must also have at least one target lesion (distinct from treatment lesion and outside of treatment lesion radiation field) evaluable for response by RECIST. This study will consist of a phase I dose escalation using a standard 3+3 design to determine safety and MTD of intralesional IL-2 which will be dose escalated in conjunction with standard fixed doses of RT and Pembrolizumab. At the MTD there will be a phase II dose expansion which will incorporate a simon-two stage design to assess efficacy and safety. Patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy.

Key Dates

Start date
May 20, 2019
Status verified
Nov 2025
Primary completion
Apr 22, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab/IL-2/Radiotherapy
    All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy.

Primary Outcome Measure

Abscopal Response Rate (ARR) [ Time Frame: Up to time of response, about 8.5 months. ]

Locations (2)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterSacramentoCalifornia95817-
University of California Davis Medical CenterSacramentoCalifornia97817-

Related coverage on Hipa.ai

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By research site
UC Davis Medical Center· Sacramento, CAUniversity of California Davis Medical Center· Sacramento, CA

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