Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03474497 | UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade | PHASE1 | ACTIVE NOT_RECRUITING | 18 | — | — | May 20, 2019 | Feb 1, 2026 | Jan 29, 2026 | 2 | United States |
To determine the abscopal response rate (ARR) defined as objective response rate (the number of patient that achieve a partial or complete response) at unirradiated sites using irRECIST criteria using imaging obtained every 60 days.
Overall response rate (ORR) defined as the number of patients that achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions
Disease control rate (DCR) defined as the number of patients whose best overall response is either complete response (CR), partial response (PR) or stable disease (SD), as assessed by Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1) for target lesions.
Progression free survival (PFS) defined as the median time from initiation of study intervention to progressive disease, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab/IL-2/Radiotherapy | EXPERIMENTAL | All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: 1. Adults ≥18 years of age with histologically proven metastatic NSCLC, melanoma, RCC, or head and neck SCC. 2. Failure to respond to checkpoint blockade therapy or previously responding patients who progress on PD-1/PD-L1 checkpoint blockade therapy. 3. ECOG (Eastern Cooperativ...