Trial Outcomes & Findings for UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade (NCT NCT03474497)

Last Updated: 2026-01-29

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Up to time of response, about 8.5 months.

Results posted on

2026-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 3 (Starting Dose) Dose Level 3 (Starting dose): IL-2: Intratumoral, 3 x10\^6 IU Tx 1, 7 x10\^6 IU Tx 2, 15 x10\^6 IU 7 x10\^6 IU Tx 3-4 Radiation therapy: 8 Gy x 3 (week 1 of Cycle 2) Pembrolizumab: 200 mg q3 weeks (3w = 1 cycle)	Dose Level 2 Dose Level 2: IL-2: Intratumoral, 3 x10\^6 IU Tx 1, 7 x10\^6 IU Tx 2-4 Radiation therapy: 8 Gy x 3 (week 1 of Cycle 2) Pembrolizumab 200 mg q3 weeks (3wk = 1 cycle)	Dose Level 1 Dose Level 1: IL-2: Intratumoral, 3 x10\^6 IU Tx 1-4 Radiation therapy: 8 Gy x 3 (week 1 of Cycle 2) Pembrolizumab 200 mg q3 weeks (3wk = 1 cycle)	Dose Level -1 Dose Level -1: IL-2: Intratumoral, 1 x10\^6 IU Tx 1-4 Radiation therapy: 8 Gy x 3 (week 1 of Cycle 2) Pembrolizumab 200 mg q3 weeks (3w = 1 cycle)
Phase 1 dose finding STARTED	7	0	0	0
Phase 1 dose finding COMPLETED	6	0	0	0
Phase 1 dose finding NOT COMPLETED	1	0	0	0
Phase 2 dose expansion STARTED	11	0	0	0
Phase 2 dose expansion COMPLETED	11	0	0	0
Phase 2 dose expansion NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab/IL-2/Radiotherapy n=18 Participants All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. 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. Pembrolizumab: Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol. 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.
Age, Categorical <=18 years	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=35 Participants
Age, Categorical >=65 years	7 Participants n=35 Participants
Sex: Female, Male Female	8 Participants n=35 Participants
Sex: Female, Male Male	10 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=35 Participants
Region of Enrollment United States	18 participants n=35 Participants

PRIMARY outcome

Timeframe: Up to time of response, about 8.5 months.

Outcome measures

Outcome measures
Measure	Pembrolizumab/IL-2/Radiotherapy n=14 Participants All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. 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. Pembrolizumab: Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol. 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.
Abscopal Response Rate (ARR)	2 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pembrolizumab/IL-2/Radiotherapy n=14 Participants All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. 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. Pembrolizumab: Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol. 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.
Overall Response Rate (ORR)	2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pembrolizumab/IL-2/Radiotherapy n=14 Participants All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. 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. Pembrolizumab: Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol. 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.
Disease Control Rate (DCR)	5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pembrolizumab/IL-2/Radiotherapy n=15 Participants All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. 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. Pembrolizumab: Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol. 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.
Progression Free Survival (PFS)	2.03 months Interval 1.8 to 7.3

SECONDARY outcome

Timeframe: Up to 90 days of treatment

To determine the maximum tolerated dose (MTD) of intralesional interleukin-2 (IL-2) that can be administered with hypofractionated radiotherapy (RT) and pembrolizumab.

Outcome measures

Outcome measures
Measure	Pembrolizumab/IL-2/Radiotherapy n=6 Participants All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. 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. Pembrolizumab: Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol. 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.
Maximum Tolerated Dose (MTD) (Phase 1)	15 x 10^6 International units (IU)

SECONDARY outcome

Timeframe: Up to about 5.5 years

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,

Outcome measures

Outcome measures
Measure	Pembrolizumab/IL-2/Radiotherapy n=18 Participants All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. 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. Pembrolizumab: Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol. 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.
Safety Profile and Toxicity	6 Participants

Adverse Events

Pembrolizumab/IL-2/Radiotherapy

Serious events: 5 serious events

Other events: 18 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab/IL-2/Radiotherapy n=18 participants at risk All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. 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. Pembrolizumab: Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol. 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.
Cardiac disorders Myocardial infarction	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Cardiac disorders Sinus tachycardia	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Abdominal pain	11.1% 2/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
General disorders Fever	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
General disorders Rigors	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Infections and infestations Sepsis	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Infections and infestations Lung infection	11.1% 2/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Anorexia	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Hypocalcemia	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Tumor lysis syndrome	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Nervous system disorders Encephalopathy	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Psychiatric disorders Confusion	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.

Other adverse events

Other adverse events
Measure	Pembrolizumab/IL-2/Radiotherapy n=18 participants at risk All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy. 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. Pembrolizumab: Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol. 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.
Blood and lymphatic system disorders Anemia	11.1% 2/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Eye disorders Blurred vision	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Abdominal pain	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Constipation	22.2% 4/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Diarrhea	22.2% 4/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Dry mouth	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Dysphagia	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Gastrointestinal disorders - Other	16.7% 3/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Mucositis oral	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Nausea	22.2% 4/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Stomach pain	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Gastrointestinal disorders Vomiting	16.7% 3/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
General disorders Chills	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
General disorders Fatigue	61.1% 11/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
General disorders Fever	22.2% 4/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
General disorders Flu like symptoms	22.2% 4/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
General disorders General disorders and administration site conditions - Other,	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
General disorders Infusion related reaction	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
General disorders Injection site reaction	22.2% 4/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Investigations Alkaline phosphatase increased	11.1% 2/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Investigations Investigations - Other	22.2% 4/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Investigations Lipase increased	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
General disorders Lymphocyte count decreased	33.3% 6/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Investigations Weight loss	11.1% 2/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Anorexia	22.2% 4/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Dehydration	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Hyperglycemia	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Hyperuricemia	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Hypomagnesemia	11.1% 2/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Hyponatremia	44.4% 8/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Hypophosphatemia	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Musculoskeletal and connective tissue disorders Myalgia	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Nervous system disorders Dizziness	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Nervous system disorders Dysgeusia	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Nervous system disorders Headache	16.7% 3/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 2/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Respiratory, thoracic and mediastinal disorders Wheezing	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Skin and subcutaneous tissue disorders Pruritus	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Skin and subcutaneous tissue disorders Rash acneiform	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	22.2% 4/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.
Vascular disorders Lymphedema	5.6% 1/18 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to about 8 months. All-cause mortality assessed from first dose until death from any cause, approximately 5.5 years.

Additional Information

Leslie Garcia

University of California, Davis

Phone: 916-734-60156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place