Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IL-2 · 1 trial · 4 indications
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...
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IL-2 is an investigational small molecule being studied for the treatment of Non Small Cell Lung Cancer. It is currently in Phase 1 clinical development. The drug is being evaluated in combination with radiotherapy and pembrolizumab in patients who are refractory to checkpoint blockade.
IL-2 is a small molecule that targets the IL-2 receptor pathway, which plays a role in modulating immune responses. By engaging this pathway, IL-2 aims to enhance anti-tumor immunity, particularly in the context of cancers like Non Small Cell Lung Cancer.
IL-2 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.
IL-2 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, with an enrollment of 18 patients.
IL-2 is being studied in a single Phase 1 clinical trial with the identifier NCT03474497. The trial, titled 'UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade,' is active but not recruiting. It enrolls patients with Non Small Cell Lung Cancer, Metastatic Melanoma, Metastatic Renal Cell Carcinoma, and Head and Neck Squamous Cell Carcinoma in the United States.
IL-2 is a small molecule that is distinct from other drugs in its class. It is being developed by Merck & Company, Inc. and is currently in Phase 1 trials for Non Small Cell Lung Cancer. No alternative names for this drug have been disclosed in the available information.