Trial Outcomes & Findings for Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC) (NCT NCT03663166)

Last Updated: 2023-02-15

Results Overview

Unacceptable toxicity defined as: * Any grade 4 immune related adverse event (irAE) * Any grade 3 irAE, excluding pneumonitis, that does not downgrade to grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to ≤ grade 1 or baseline within 14 days * Liver transaminase elevation \> 8 × ULN or total bilirubin \> 5 × ULN, * Any ≥ grade 3 non-irAE, with some exclusions. Result is provided as number of participants with unacceptable toxicity within 8 weeks of commencing study therapy.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

19 participants

Primary outcome timeframe

At 8 weeks of treatment

Results posted on

2023-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Radiation and Chemotherapy, Followed by Nivolumab Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and ipilimumab . Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology). Ipilimumab: Ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression. Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
Overall Study STARTED	19
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation and Chemotherapy, Followed by Nivolumab Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and ipilimumab . Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology). Ipilimumab: Ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression. Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation and Chemotherapy, Followed by Nivolumab n=19 Participants Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab. Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology). Ipilimumab: ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression. Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants
Age, Categorical >=65 years	10 Participants n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	17 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	19 participants n=93 Participants

PRIMARY outcome

Timeframe: At 8 weeks of treatment

Outcome measures

Outcome measures
Measure	Radiation and Chemotherapy, Followed by Nivolumab n=19 Participants Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab. Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology). Ipilimumab: Ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression. Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
Unacceptable Toxicity Status at the End of 8-week Safety Observation Period	6 Participants

PRIMARY outcome

Timeframe: 12 months post treatment

Disease Progression defined as the duration from date of registration to date of first documentation of progression as defined using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and assessed by local investigator or symptomatic deterioration (as defined in Outcome 1) or death due to any cause. Patients last known to be alive without report of progression are censored at date of last disease assessment. For patients with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) will be used as the date of progression.

Outcome measures

Outcome measures
Measure	Radiation and Chemotherapy, Followed by Nivolumab n=19 Participants Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab. Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology). Ipilimumab: Ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression. Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
Percentage of Participants Without Disease Progression at 12 Months	58 percentage of participants Interval 33.0 to 76.0

SECONDARY outcome

Timeframe: 12 months post treatment

DMFS is defined as the duration from date of registration to date of first documentation of distant metastatic progression beyond the primary tumor site as well as regional lymph nodes assessed by local investigator or symptomatic deterioration (as defined in Outcome 1) or death due to any cause. Patients last known to be alive without report of distant metastatic progression are censored at date of last disease assessment.

Outcome measures

Outcome measures
Measure	Radiation and Chemotherapy, Followed by Nivolumab n=19 Participants Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab. Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology). Ipilimumab: Ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression. Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
Percentage of Participants Who Experienced 12 Month Distant Metastasis Free Survival (DMFS)	63.2 percentage of participants Interval 41.7 to 85.0

SECONDARY outcome

Timeframe: 6 months

ORR is defined as the proportion of all treated subjects whose best overall response is either a complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Best Objective Response (BOR) will also be reported Complete Response (CR) or Partial Response (PR) determinations included in the assessment must be confirmed by a consecutive second (confirmatory) evaluation meeting the criteria for response that is performed at least 4 weeks after the criteria for response are first met. When Stable Disease (SD) is believed to be the best response, it must meet a minimum SD duration of 49 days. Measurements must have met the SD criteria at least once after study entry.

Outcome measures

Outcome measures
Measure	Radiation and Chemotherapy, Followed by Nivolumab n=19 Participants Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab. Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology). Ipilimumab: Ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression. Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
Objective Response Rate (ORR) at 6 Months	66 percentage of participants Interval 41.0 to 87.0

Adverse Events

Radiation and Chemotherapy, Followed by Nivolumab

Serious events: 13 serious events

Other events: 19 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Radiation and Chemotherapy, Followed by Nivolumab n=19 participants at risk Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab. Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology). Ipilimumab: Ipilimumab1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression. Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
Gastrointestinal disorders Dehydration	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Diarrhea	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Lung infection	15.8% 3/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Cardiac disorders Atrial fibrilation	10.5% 2/19 • Number of events 3 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Hypomagnesemia	5.3% 1/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Vascular disorders Thromboembolic event	10.5% 2/19 • Number of events 3 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Blood and lymphatic system disorders Anemia	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Gastrointestinal disorders - Other	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Blood and lymphatic system disorders Febrile neutropenia	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Atelectasis	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	21.1% 4/19 • Number of events 8 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Cardiac disorders Sinus tachycardia	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	15.8% 3/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Nervous system disorders Stroke	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
General disorders Fatigue	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Hyponatremia	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Nervous system disorders Syncope	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Investigations - Other	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Mucositis oral	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Creatinine increased	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Neutrophil count decreased	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.

Other adverse events

Other adverse events
Measure	Radiation and Chemotherapy, Followed by Nivolumab n=19 participants at risk Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab. Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology). Ipilimumab: Ipilimumab1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression. Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
Gastrointestinal disorders Esophagitis	68.4% 13/19 • Number of events 19 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Constipation	47.4% 9/19 • Number of events 12 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Dysphagia	42.1% 8/19 • Number of events 12 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Nausea	36.8% 7/19 • Number of events 11 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Diarrhea	31.6% 6/19 • Number of events 8 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Vomiting	26.3% 5/19 • Number of events 9 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Gastroesophageal reflux disease	21.1% 4/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Gastrointestinal disorders - Other	21.1% 4/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Dry mouth	15.8% 3/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Abdominal pain	10.5% 2/19 • Number of events 3 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Dyspepsia	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Hemorrhoids	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Belching	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Colitis	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Oral pain	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
General disorders Fatigue	63.2% 12/19 • Number of events 23 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
General disorders Edema limbs	26.3% 5/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
General disorders Pain	21.1% 4/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Gastrointestinal disorders Chills	15.8% 3/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
General disorders Fever	15.8% 3/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
General disorders Malaise	15.8% 3/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
General disorders Non-cardiac chest pain	10.5% 2/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
General disorders Flu like symptoms	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	52.6% 10/19 • Number of events 22 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	31.6% 6/19 • Number of events 12 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	31.6% 6/19 • Number of events 7 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Cough	26.3% 5/19 • Number of events 11 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	26.3% 5/19 • Number of events 7 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Atelectasis	21.1% 4/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Productive cough	21.1% 4/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Wheezing	21.1% 4/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.5% 2/19 • Number of events 3 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	10.5% 2/19 • Number of events 3 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.5% 2/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Sore throat	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.3% 1/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Respiratory, thoracic and mediastinal disorders Sleep apnea	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Weight loss	31.6% 6/19 • Number of events 21 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Creatinine increased	15.8% 3/19 • Number of events 14 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Lipase increased	15.8% 3/19 • Number of events 8 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Platelet count decreased	15.8% 3/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Weight gain	15.8% 3/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Alanine aminotransferase increased	10.5% 2/19 • Number of events 8 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Lymphocyte count decreased	10.5% 2/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Neutrophil count decreased	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Serum amylase increased	10.5% 2/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations White blood cell decreased	10.5% 2/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Aspartate aminotransferase increased	5.3% 1/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Investigations Investigations - Other	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Anorexia	42.1% 8/19 • Number of events 9 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Dehydration	31.6% 6/19 • Number of events 8 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Hypokalemia	21.1% 4/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Acidosis	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Hypoalbuminemia	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Hypomagnesemia	5.3% 1/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Hyponatremia	5.3% 1/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Hypophosphatemia	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Psychiatric disorders Anxiety	42.1% 8/19 • Number of events 8 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Psychiatric disorders Insomnia	42.1% 8/19 • Number of events 10 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Psychiatric disorders Confusion	15.8% 3/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Psychiatric disorders Depression	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Psychiatric disorders Agitation	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Thrush	31.6% 6/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Lung infection	26.3% 5/19 • Number of events 7 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Sinusitis	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Bronchial infection	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Infections and infestations - Other	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Mucosal infection	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Pelvic infection	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Sepsis	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Urinary tract infection	5.3% 1/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Infections and infestations Vaginal infection	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	21.1% 4/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	21.1% 4/19 • Number of events 7 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Pain in extremity	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Back pain	5.3% 1/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Chest wall pain	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Flank pain	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Muscle cramp	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Musculoskeletal and connective tissue disorders Myositis	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Nervous system disorders Dizziness	31.6% 6/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Nervous system disorders Dysgeusia	26.3% 5/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Nervous system disorders Headache	26.3% 5/19 • Number of events 7 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Nervous system disorders Stroke	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Nervous system disorders Syncope	5.3% 1/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Nervous system disorders Tremor	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Injury, poisoning and procedural complications Dermatitis radiation	36.8% 7/19 • Number of events 12 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	10.5% 2/19 • Number of events 3 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Injury, poisoning and procedural complications Fracture	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Injury, poisoning and procedural complications Infusion related reaction	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Vascular disorders Hypotension	21.1% 4/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Vascular disorders Thromboembolic event	21.1% 4/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Vascular disorders Hypertension	15.8% 3/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Vascular disorders Hematoma	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Vascular disorders Vascular disorders - Other	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Blood and lymphatic system disorders Anemia	42.1% 8/19 • Number of events 16 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	10.5% 2/19 • Number of events 3 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Blood and lymphatic system disorders Disseminated intravascular coagulation	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Blood and lymphatic system disorders Eosinophilia	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Blood and lymphatic system disorders Febrile neutropenia	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Cardiac disorders Sinus tachycardia	26.3% 5/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Cardiac disorders Atrial fibrillation	10.5% 2/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Cardiac disorders Atrial flutter	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	21.1% 4/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	21.1% 4/19 • Number of events 5 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Skin and subcutaneous tissue disorders Pruritus	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Skin and subcutaneous tissue disorders Alopecia	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Skin and subcutaneous tissue disorders Dry skin	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Skin and subcutaneous tissue disorders Rash acneiform	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Skin and subcutaneous tissue disorders Urticaria	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Eye disorders Blurred vision	15.8% 3/19 • Number of events 3 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Eye disorders Dry eye	10.5% 2/19 • Number of events 3 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Eye disorders Eye disorders - Other	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Eye disorders Floaters	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Eye disorders Retinal detachment	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Endocrine disorders Hypothyroidism	21.1% 4/19 • Number of events 6 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Endocrine disorders Endocrine disorders - Other	10.5% 2/19 • Number of events 3 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Endocrine disorders Hyperthyroidism	10.5% 2/19 • Number of events 4 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Ear and labyrinth disorders Tinnitus	10.5% 2/19 • Number of events 2 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Ear and labyrinth disorders Vertigo	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Renal and urinary disorders Acute kidney injury	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Renal and urinary disorders Renal calculi	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Renal and urinary disorders Urinary frequency	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Renal and urinary disorders Urinary incontinence	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Renal and urinary disorders Urinary urgency	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Immune system disorders Allergic reaction	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.
Reproductive system and breast disorders Testicular pain	5.3% 1/19 • Number of events 1 • Adverse Events collected from on study date to 100 days after study drug discontinuation, approximately 14 months.

Additional Information

Bradford A. Perez, MD

Moffitt Cancer Center

Phone: 813-745-4380

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place