Trial Outcomes & Findings for Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer (NCT NCT05014776)

Last Updated: 2025-04-16

Results Overview

Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

9 months

Results posted on

2025-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Overall Study STARTED	17
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 n=17 Participants Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 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	2 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	5 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Outcome measures

Outcome measures
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 n=17 Participants Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)	0 Participants

SECONDARY outcome

Timeframe: 9 months

Outcome measures

Outcome measures
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 n=17 Participants Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation	0 Participants

Adverse Events

Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207

Serious events: 12 serious events

Other events: 17 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 n=17 participants at risk Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Gastrointestinal disorders Abdominal pain	17.6% 3/17 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Blood and lymphatic system disorders Anemia	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Biliary Obstruction	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Bowel Obstruction	11.8% 2/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Hepatobiliary disorders Cholangitis	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Disease Progression	64.7% 11/17 • Number of events 11 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Hepatobiliary disorders Hepatic failure	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Infections and infestations Lung infection	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Infections and infestations Sepsis	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Stroke	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.

Other adverse events

Other adverse events
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 n=17 participants at risk Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Gastrointestinal disorders Bloating	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Abdominal pain	29.4% 5/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Alanine aminotransferase increased	23.5% 4/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Alkaline phosphatase increased	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	23.5% 4/17 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Blood and lymphatic system disorders Anemia	11.8% 2/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Anorexia	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Psychiatric disorders Anxiety	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Arthralgia	23.5% 4/17 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Ascites	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Aspartate aminotransferase increased	17.6% 3/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Back pain	11.8% 2/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Bone pain	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Bruising	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Chills	100.0% 17/17 • Number of events 39 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Cough	29.4% 5/17 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Creatinine increased	17.6% 3/17 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Dark stool	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Psychiatric disorders Depression	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Diarrhea	29.4% 5/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Dizziness	11.8% 2/17 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Dry mouth	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Dry skin	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Dysphasia	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.8% 2/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Edema	35.3% 6/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Injury, poisoning and procedural complications Fall	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Fatigue	41.2% 7/17 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Fever	88.2% 15/17 • Number of events 37 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Flank pain	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Flatulence	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Eye disorders Floaters	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Fracture	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Headache	41.2% 7/17 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Vascular disorders Hypertension	52.9% 9/17 • Number of events 13 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Endocrine disorders Hyperthyroidism	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Vascular disorders Hypotension	29.4% 5/17 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Endocrine disorders Hypothyroidism	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Infections and infestations COVID Infection	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Injury, poisoning and procedural complications Infusion related reaction	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Psychiatric disorders Insomnia	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Lethargy	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Blood and lymphatic system disorders Lymphocyte count decreased	58.8% 10/17 • Number of events 23 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Myalgia	35.3% 6/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Nausea	23.5% 4/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Non-cardiac chest pain	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Pain	41.2% 7/17 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Pain in extremity	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Eye disorders Photophobia	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Blood and lymphatic system disorders Platelet count decreased	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Pleural hemorrhage	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Postnasal drip	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Pruritus	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Infections and infestations Shingles	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Cardiac disorders Sinus tachycardia	29.4% 5/17 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Lump	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Skin ulceration	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Somnolence	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Sore throat	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Injury, poisoning and procedural complications Spinal fracture	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Thyroid stimulating hormone increased	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Ear and labyrinth disorders Tinnitus	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Reproductive system and breast disorders Vaginal discharge	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Vomiting	23.5% 4/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Weight gain	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Weight loss	47.1% 8/17 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.

Additional Information

Katherine Bever, MD

SKCCC Johns Hopkins Medical Institution

Phone: 443-287-0966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place