Trial Outcomes & Findings for Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk (NCT NCT03436862)

NCT ID: NCT03436862

Last Updated: 2023-12-05

Results Overview

Adverse events will be graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE version 4.03).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: Every 2 weeks up to a maximum of 6 months of treatment, then up to 100 days after treatment discontinuation
• Results posted on: 2023-12-05

Participant Flow

Participant milestones

Measure	Nivolumab Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment. Nivolumab: Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.
Overall Study STARTED	37
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Nivolumab Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment. Nivolumab: Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.
Overall Study Adverse Event	4
Overall Study Progressive Disease	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Nivolumab n=37 Participants Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment. Nivolumab: Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.
Age, Continuous	36 years n=37 Participants
Sex: Female, Male Female	12 Participants n=37 Participants
Sex: Female, Male Male	25 Participants n=37 Participants

PRIMARY outcome

Timeframe: Every 2 weeks up to a maximum of 6 months of treatment, then up to 100 days after treatment discontinuation

Population: All participants who have received at least one dose of study drug (Nivolumab) treatment.

Adverse events will be graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE version 4.03).

Outcome measures

Measure	Nivolumab n=37 Participants Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment. Nivolumab: Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of Nivolumab as Maintenance Therapy	33 Participants

SECONDARY outcome

Timeframe: 1 year after date of first dose of study drug for each patient

Population: All participants who have received at least one dose of study treatment (Nivolumab).

Kaplan-Meier PFS estimate at 12 month interval when nivolumab is administered as maintenance therapy. Progression-Free Survival (PFS), defined as the time from the first day of study drug administration (Day 1) to disease progression as defined by the Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification (Cheson et al. 2014), or death on study. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment.

Outcome measures

Measure	Nivolumab n=37 Participants Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment. Nivolumab: Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.
Progression-free Survival (PFS) Kaplan-Meier Estimate at 12 Month Interval	NA percentage of participants Since so few patients progressed or died, the median progression-free survival estimate at 12 months after first dose was not estimable by Kaplan-Meier method nor the 95% confidence interval.

Adverse Events

Nivolumab

Serious events: 4 serious events

Other events: 37 other events

Deaths: 2 deaths

Serious adverse events

Measure	Nivolumab n=37 participants at risk Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment. Nivolumab: Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.
General disorders Pyrexia	2.7% 1/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	2.7% 1/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 1/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.7% 1/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Other adverse events

Measure	Nivolumab n=37 participants at risk Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment. Nivolumab: Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.
Blood and lymphatic system disorders Anaemia	10.8% 4/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Ear and labyrinth disorders Vertigo	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Eye disorders Vision blurred	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders Constipation	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders Diarrhoea	27.0% 10/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders Dry mouth	10.8% 4/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders Flatulence	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders Nausea	16.2% 6/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders Vomiting	8.1% 3/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders Catheter site pain	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders Fatigue	27.0% 10/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders Pain	8.1% 3/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders Pyrexia	10.8% 4/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations Upper respiratory tract infection	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Injury, poisoning and procedural complications Fall	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations Alanine aminotransferase increased	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations Aspartate aminotransferase increased	8.1% 3/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations Lymphocyte count decreased	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations White blood cell count decreased	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders Hyperglycaemia	10.8% 4/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders Arthralgia	8.1% 3/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders Back pain	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders Bone pain	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders Muscle spasms	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders Myalgia	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders Dizziness	8.1% 3/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders Headache	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders Neuropathy peripheral	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Cough	32.4% 12/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Nasal congestion	16.2% 6/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.1% 3/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Sinus congestion	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders Erythema	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders Pruritus	16.2% 6/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders Rash	8.1% 3/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Vascular disorders Flushing	5.4% 2/37 • Serious and/or other adverse events were assessed from the date of first dose to 100 days after last dose of study treatment, up to approximately 280 days. All-Cause Mortality was monitored from date of consent to 2 years after last dose of study treatment, approximately 2.5 years. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Additional Information

Sarah Cannon Development Innovations, LLC

Sarah Cannon Development Innovations, LLC

Phone: 844-710-6157

Email: CANN.InnovationsMedical@sarahcannon.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60