Non Small Cell Lung CancerPhase 1/2NCT03474497
UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade
A Phase 1/2 study testing IL-2, Pembrolizumab and Radiotherapy in people with Non Small Cell Lung Cancer and Metastatic Melanoma, run by Megan Daly, MD at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Metastatic Melanoma, Metastatic Renal Cell Carcinoma
- What is being tested?
- IL-2, Pembrolizumab and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2019to Feb 2026
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age with histologically proven metastatic NSCLC, melanoma, RCC, or head and neck SCC.
- Failure to respond to checkpoint blockade therapy or previously responding patients who progress on PD-1/PD-L1 checkpoint blockade therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0 - 1 (Appendix 1)
- Presence of a candidate treatment lesion (subcutaneous or nodal lesions are preferable but visceral lesions will be considered) accessible and safe for radiotherapy and serial intralesional injections.
- Presence of at least one target lesion (distinct from treatment lesion and outside of treatment lesion radiation field) evaluable for response by irRECIST
- Life expectancy ≥ 6 months
Show all 19Show fewer
- Demonstrate adequate organ function as defined in Table 2, all screening labs should be performed within 10 days of treatment initiation.
- (Note: see protocol for table 2)
- No other active malignancy.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days after the last dose of study medication.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Signed informed consent.
- Ability to comply with the protocol.
- Systolic ≥80.
- No active auto-immune disease and not on therapy for auto-immune disease.
- Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible.
Who cannot join
- Uncontrolled concomitant disease.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Use of inhaled or topical steroids or systemic corticosteroids < 10 mg/ day is permitted.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) (excluding PD-1/PD-L1 inhibitor) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Show all 25Show fewer
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- History of severe autoimmune disease.
- Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment (with the exception of checkpoint blockade therapy).
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications within past 4 weeks or 5 half-lives whichever is shorter. Use of inhaled or topical steroids or systemic corticosteroids < 10 mg/ day is permitted.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Patients unable to tolerate checkpoint inhibitor therapy.
- Unresolved Grade 3 or any grade 4 non-hematological, treatment-related AEs attributed to prior PD-1/ PD-L1 checkpoint blockade. A minimum of 2 weeks from prior PD-1/PD-L1 checkpoint blockade to initiating study treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC Davis Medical Center
Sacramento, California, 95817
University of California Davis Medical Center
Sacramento, California, 97817
About this study
Official title: UCDCC#272: A Phase I/II Study of Intralesional IL-2, Hypofractionated Radiotherapy, and Pembrolizumab in Patients Refractory to Standard-of-Care PD-1/PD-L1 Checkpoint Blockade
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.
Read the detailed description
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.
- 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.
- Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol.
- 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.
Patients will be assessed by a physician once during the first week of radiotherapy, during each intralesional IL-2 injection, and with every cycle of pembrolizumab during the first three cycles. Thereafter patients will be assessed every 30 days during the study period and will continue until disease progression. All patients on active treatment will be discussed at weekly conferences of the trial investigators. Routine laboratory evaluation will occur pre-treatment and every 30 days. For response assessment patient will have imaging pre-treatment and after every three cycles of Pembrolizumab. For collateral studies patients will undergo mandatory treatment lesion biopsies and blood draws pre-treatment and during the needle placement for the final IL-2 treatment.
Preliminary efficacy as determined by abscopal response rate, ORR, DCR and PFS will be assessed every 3 cycles. The patient will remain on protocol treatment until progression as determined by irRECIST, treatment is no longer tolerated, or the patient has completed 12 months of treatment. Patients on active treatment at 12 months may continue to receive pembrolizumab but will revert to standard of care (SOC) management and be labeled in "follow up". At this time only PFS and long-term toxicity data will be collected every 3 months.
The primary endpoint is to determine if this regimen converts patients with resistance to PD 1/PD-L1 checkpoint blockade into responders as determined by abscopal response rate (defined as response rate at lesions not treated with RT + IL-2) using irRECIST as well as ORR, DCR, and PFS using RECIST 1.1. The secondary endpoint is tolerability, safety, and toxicity using CTCAE v4.03. Correlative studies include immunophenotyping serial tumor biopsies and blood samples.
- Conditions
- Non Small Cell Lung Cancer, Metastatic Melanoma, Metastatic Renal Cell Carcinoma, Head and Neck Squamous Cell Carcinoma
- Being tested
- IL-2, Pembrolizumab, Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Carcinoma, Renal Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-2Drug
- 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.
PembrolizumabDrug
Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol.
RadiotherapyRadiation
Also called Radiation Therapy
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 group | Role | What they receive |
|---|---|---|
| Pembrolizumab/IL-2/Radiotherapy | Experimental | All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. Receives: Drug: IL-2; Drug: Pembrolizumab; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abscopal Response Rate (ARR)
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.
Measured: Up to time of response, about 8.5 months.
Overall Response Rate (ORR)
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
Measured: Up to time of response, about 8.5 months.
Disease Control Rate (DCR)
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.
Measured: Up to about 10 months.
Progression Free Survival (PFS)
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.
Measured: Up to about 7.3 months.
Secondary outcomes (2)
Maximum Tolerated Dose (MTD) (Phase 1)
To determine the maximum tolerated dose (MTD) of intralesional interleukin-2 (IL-2) that can be administered with hypofractionated radiotherapy (RT) and pembrolizumab.
Measured: Up to 90 days of treatment
Safety Profile and Toxicity
Safety profile and toxicity of intralesional interleukin-2 (IL-2), radiotherapy (RT), and pembrolizumab defined as the number of patients experiencing treatment related adverse events (AE) grade ≥ 3, using CTCAE v4.03 (Common Toxicity Criteria for Adverse Events version 4.03,
Measured: Up to about 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start20 May 2019
- Primary completion22 Apr 2025
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Megan Daly, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Megan Daly, MD, University of California, Davis
- Investigators
- Megan Daly, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474497
- Sponsor's protocol ID
- 1166212
- Status last verified
- Nov 2025
- First submitted
- 15 Mar 2018
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCDCC#272: A Phase I/II Study of Intralesional IL-2, Hypofractionated Radiotherapy, and Pembrolizumab in Patients Refractory to Standard-of-Care PD-1/PD-L1 Checkpoint Blockade
- ClinicalTrials.gov ID
- NCT03474497
- Acronym / sponsor ID
- 1166212
- Conditions
- Non Small Cell Lung Cancer, Metastatic Melanoma, Metastatic Renal Cell Carcinoma, Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Megan Daly, MDUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 20 May 2019 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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.
- Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol.
- 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.
Patients will be assessed by a physician once during the first week of radiotherapy, during each intralesional IL-2 injection, and with every cycle of pembrolizumab during the first three cycles. Thereafter patients will be assessed every 30 days during the study period and will continue until disease progression. All patients on active treatment will be discussed at weekly conferences of the trial investigators. Routine laboratory evaluation will occur pre-treatment and every 30 days. For response assessment patient will have imaging pre-treatment and after every three cycles of Pembrolizumab. For collateral studies patients will undergo mandatory treatment lesion biopsies and blood draws pre-treatment and during the needle placement for the final IL-2 treatment.
Preliminary efficacy as determined by abscopal response rate, ORR, DCR and PFS will be assessed every 3 cycles. The patient will remain on protocol treatment until progression as determined by irRECIST, treatment is no longer tolerated, or the patient has completed 12 months of treatment. Patients on active treatment at 12 months may continue to receive pembrolizumab but will revert to standard of care (SOC) management and be labeled in "follow up". At this time only PFS and long-term toxicity data will be collected every 3 months.
The primary endpoint is to determine if this regimen converts patients with resistance to PD 1/PD-L1 checkpoint blockade into responders as determined by abscopal response rate (defined as response rate at lesions not treated with RT + IL-2) using irRECIST as well as ORR, DCR, and PFS using RECIST 1.1. The secondary endpoint is tolerability, safety, and toxicity using CTCAE v4.03. Correlative studies include immunophenotyping serial tumor biopsies and blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab/IL-2/Radiotherapy | Experimental | Drug: IL-2, Drug: Pembrolizumab, Radiation: RadiotherapyAll patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adults ≥18 years of age with histologically proven metastatic NSCLC, melanoma, RCC, or head and neck SCC.
- Failure to respond to checkpoint blockade therapy or previously responding patients who progress on PD-1/PD-L1 checkpoint blockade therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0 - 1 (Appendix 1)
- Presence of a candidate treatment lesion (subcutaneous or nodal lesions are preferable but visceral lesions will be considered) accessible and safe for radiotherapy and serial intralesional injections.
- Presence of at least one target lesion (distinct from treatment lesion and outside of treatment lesion radiation field) evaluable for response by irRECIST
Key exclusion criteria (25 listed)
- Uncontrolled concomitant disease.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Use of inhaled or topical steroids or systemic corticosteroids < 10 mg/ day is permitted.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-2• 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. | Drug | Pembrolizumab/IL-2/Radiotherapy |
| PembrolizumabPembrolizumab will be delivered at 200 mg in three week cycles per standard protocol. | Drug | Pembrolizumab/IL-2/Radiotherapy |
| RadiotherapyAlso: Radiation TherapyRadiotherapy 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. | Radiation | Pembrolizumab/IL-2/Radiotherapy |
Primary outcome
Abscopal Response Rate (ARR)
Time frame: Up to time of response, about 8.5 months.
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)
Time frame: Up to time of response, about 8.5 months.
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)
Time frame: Up to about 10 months.
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)
Time frame: Up to about 7.3 months.
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.
2 secondary outcomes
Maximum Tolerated Dose (MTD) (Phase 1)
Time frame: Up to 90 days of treatment
Safety Profile and Toxicity
Time frame: Up to about 5.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Learn more or sign up for the study here!Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Daly, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IL-2, Pembrolizumab and Radiotherapy in people with Non Small Cell Lung Cancer and Metastatic Melanoma, run by Megan Daly, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abscopal Response Rate (ARR) (time frame: Up to time of response, about 8.5 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.