Trial Outcomes & Findings for Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma (NCT NCT03259425)

Last Updated: 2022-06-13

Results Overview

Following 12 weeks of neoadjuvant treatment with nivolumab and HF10, participants underwent definitive surgery. A percent viable tumor was assessed semi-quantitatively in the definitive surgical resection specimen by estimating the proportion of residual tumor in relation to the total tumor area and reported as percentage viability. A pathologic complete response was defined as no viable residual melanoma cells in the surgical specimen. A major pathologic response was defined as \<50% viable tumor cells. A minor pathologic response was defined as 50% or greater viable tumor cells, including specimens that had 100% viability at surgery.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

at time of surgery (12 weeks)

Results posted on

2022-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Nivolumab and HF10 (All Participants) Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Overall Study STARTED	7
Overall Study Surgery	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nivolumab and HF10 (All Participants) Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Overall Study Disease progression to an extent that didn't allow surgery	1

Baseline Characteristics

Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab and HF10 (All Participants ) n=7 Participants Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Tumor Viability Percentage Tumor Viability >= 90%	7 Participants n=5 Participants
Tumor Viability Percentage Tumor Viability < 90%	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: at time of surgery (12 weeks)

Population: One of seven participants had progressive disease while receiving neoadjuvant therapy and did not receive surgical resection and therefore per protocol was not assessed for response.

Outcome measures

Outcome measures
Measure	Nivolumab and HF10 (All Participants) n=6 Participants Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Pathological Response Pathologic Complete Response (0% Tumor Viability)	5 Participants
Pathological Response Major Pathologic Response (<50% Tumor Viability)	0 Participants
Pathological Response Minor Pathologic Response (>=50% Tumor Viability)	1 Participants

SECONDARY outcome

Timeframe: up to 2 years post-surgery (1 year after end of adjuvant nivolumab, which was given for up to 1 year post-surgery)

Population: The participant who did not complete surgery was not followed for post-surgery outcomes.

Recurrence after surgery will be assessed by radiologic scans and confirmed by biopsy. Death within the follow-up period is also considered recurrence. This outcome will report the number of participants who were alive and who had no disease recurrence during the follow-up period.

Outcome measures

Outcome measures
Measure	Nivolumab and HF10 (All Participants) n=6 Participants Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Recurrence-free Survival: Number of Participants With no Disease Recurrence After Surgery	2 Participants

SECONDARY outcome

Timeframe: up to 2 years post-surgery (1 year after end of adjuvant nivolumab, which was given for up to 1 year post-surgery)

Population: The participant who did not complete surgery was not followed for post-surgery outcomes.

Participants were followed for survival for one year after completion of adjuvant nivolumab. Adjuvant nivolumab was planned for up to one year of adjuvant treatment after surgery. This objective reports the number of participants who were alive one year after the completion of adjuvant nivolumab.

Outcome measures

Outcome measures
Measure	Nivolumab and HF10 (All Participants) n=6 Participants Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Overall Survival: Number of Participants Alive One Year After Completing Adjuvant Nivolumab	5 Participants

SECONDARY outcome

Timeframe: 12 weeks from baseline to surgery

Participants were assessed radiographically and clinically prior to study start and prior to surgery. Lesions were measured, and lesions that were at least 10 mm on CT, MRI, caliper, or ruler, or at least 20 mm on x-ray were documented as Target Lesions. Lesions that did not meet criteria to be Target Lesions were documented as Non-Target lesions. Measurements of Target Lesions were summed. Change in Target Lesion measurements was used to determine response by RECIST 1.1 criteria. Complete Response (CR) indicates a disappearance of all lesions. Partial Response (PR) indicates at least 30% decrease in the sum of Target Lesions. Progressive Disease (PD) indicates at least 20% increase in the sum of Target Lesions, or the appearance of one or more new lesions after baseline. Stable Disease (SD) is neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Objective was reported as number of participants within each response category.

Outcome measures

Outcome measures
Measure	Nivolumab and HF10 (All Participants) n=7 Participants Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Radiographic Response: Number of Participants Within Each Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Response Category Complete Response (CR)	1 Participants
Radiographic Response: Number of Participants Within Each Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Response Category Partial Response (PR)	0 Participants
Radiographic Response: Number of Participants Within Each Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Response Category Stable Disease (SD)	3 Participants
Radiographic Response: Number of Participants Within Each Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Response Category Progressive Disease (PD)	3 Participants

SECONDARY outcome

Timeframe: Within 28 days after Day 84

Population: The participant who did not complete surgery was not followed for post-surgery outcomes.

Participants' surgical samples were assessed by a pathologist after surgery to determine if complete surgical resection was achieved after neo-adjuvant treatment with nivolumab and HF10. R0 indicates a complete surgical resection was achieved and means no residual tumor was detected after after surgery. R1 means microscopic tumor was detected and a complete surgical resection was not achieved.

Outcome measures

Outcome measures
Measure	Nivolumab and HF10 (All Participants) n=6 Participants Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Number of Participants With Complete Surgical Resection R0 Complete Surgical Resection	5 Participants
Number of Participants With Complete Surgical Resection R1 Incomplete Surgical Resection	1 Participants

SECONDARY outcome

Timeframe: throughout HF10 treatment (up to 84 days)

Participants were monitored for adverse events (AEs) during treatment with HF10 using CTCAE v4 criteria. AEs were graded as being mild (grade 1), moderate (grade 2), grade 3 (severe), grade 4 (life-threatening), and grade 5 (fatal). Each adverse event was reviewed by a treating investigator for relatedness to study treatment. For this outcome, the number of participants who experienced any AEs that were possible, probably, or definitely related to HF10 treatment are grouped by grade 1-2 and grade 3-5 AEs.

Outcome measures

Outcome measures
Measure	Nivolumab and HF10 (All Participants) n=7 Participants Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Number of Participants With Adverse Events Related to HF10 Treatment Participants with G1-2 AEs related to HF10	7 Participants
Number of Participants With Adverse Events Related to HF10 Treatment Participants with G3-5 AEs related to HF10	1 Participants

SECONDARY outcome

Timeframe: throughout nivolumab treatment (up to 84 days prior to surgery and up to 1 year after surgery)

Participants were monitored for adverse events (AEs) during treatment with nivolumab using CTCAE v4 criteria. AEs were graded as being mild (grade 1), moderate (grade 2), grade 3 (severe), grade 4 (life-threatening), and grade 5 (fatal). Each adverse event was reviewed by a treating investigator for relatedness to study treatment. For this outcome, the number of participants who experienced any AEs that were possible, probably, or definitely related to nivolumab treatment are grouped by grade 1-2 and grade 3-5 AEs.

Outcome measures

Outcome measures
Measure	Nivolumab and HF10 (All Participants) n=7 Participants Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Number of Participants With Adverse Events Related to Nivolumab Treatment Participants with G1-2 AEs related to Nivolumab	7 Participants
Number of Participants With Adverse Events Related to Nivolumab Treatment Participants with G3-5 AEs related to Nivolumab	2 Participants

Adverse Events

Nivolumab and HF10 (All Participants)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab and HF10 (All Participants) n=7 participants at risk Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Renal and urinary disorders Acute kidney injury	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Endocrine disorders Adrenal insufficiency	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Blood and lymphatic system disorders Anemia	14.3% 1/7 • Number of events 2 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Cardiac disorders Cardiac disorders - Other, specify	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Endocrine disorders Endocrine disorders - Other, specify	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Esophagitis	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Fatigue	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Cardiac disorders Heart failure	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Metabolism and nutrition disorders Hyponatremia	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Productive cough	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Respiratory failure	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Infections and infestations Sepsis	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	14.3% 1/7 • Number of events 2 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Vascular disorders Thromboembolic event	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.

Other adverse events

Other adverse events
Measure	Nivolumab and HF10 (All Participants) n=7 participants at risk Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year. HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Blood and lymphatic system disorders Anemia	14.3% 1/7 • Number of events 2 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Metabolism and nutrition disorders Anorexia	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Psychiatric disorders Anxiety	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Arthralgia	28.6% 2/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Bone pain	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Chills	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Constipation	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 2/7 • Number of events 3 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Investigations Creatinine increased	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Metabolism and nutrition disorders Dehydration	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Psychiatric disorders Depression	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Dizziness	28.6% 2/7 • Number of events 5 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Eye disorders Dry eye	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Dry mouth	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Dyspnea	28.6% 2/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Infections and infestations Eye infection	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Injury, poisoning and procedural complications Fall	28.6% 2/7 • Number of events 3 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Fatigue	71.4% 5/7 • Number of events 9 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Flu like symptoms	71.4% 5/7 • Number of events 6 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Reproductive system and breast disorders Genital edema	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Hiccups	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Hoarseness	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Vascular disorders Hypotension	14.3% 1/7 • Number of events 3 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Endocrine disorders Hypothyroidism	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Hypoxia	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Infusion related reaction	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Injection site reaction	28.6% 2/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Localized edema	14.3% 1/7 • Number of events 2 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Infections and infestations Mucosal infection	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 1/7 • Number of events 2 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Nausea	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Nervous system disorders - Other, specify	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Pain	14.3% 1/7 • Number of events 2 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Pain in extremity	28.6% 2/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Peripheral motor neuropathy	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Productive cough	28.6% 2/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • Number of events 2 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Rash maculo-papular	71.4% 5/7 • Number of events 6 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Cardiac disorders Sinus bradycardia	14.3% 1/7 • Number of events 2 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	42.9% 3/7 • Number of events 7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Infections and infestations Skin infection	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Sore throat	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Surgical and medical procedures Surgical and medical procedures - Other, specify	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Reproductive system and breast disorders Testicular pain	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Toothache	14.3% 1/7 • From first dose of study treatment to 30 days after last dose of study treatment (up to 1 year, 8 months) Per protocol: The occurrence of adverse events should be sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.

Additional Information

Data Manager, Research Compliance Office

Huntsman Cancer Institute

Phone: 8015850601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place