Trial Outcomes & Findings for MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery (NCT NCT00112580)

NCT ID: NCT00112580

Last Updated: 2021-09-27

Results Overview

Percentage of participants who achieved Complete Response (CR) or Partial Response (PR) according to RECIST criteria. Particularly, CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease n the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: From first dose to 3 weeks following the end of the treatment cycle, up to 24 weeks.
• Results posted on: 2021-09-27

Participant Flow

27 participants were treated.

Participant milestones

Measure	Locally Advanced Cohort Participants with locally advanced pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.	Metastatic Cohort Participants with metastatic pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
Overall Study STARTED	8	19
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	8	19

Reasons for withdrawal

Measure	Locally Advanced Cohort Participants with locally advanced pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.	Metastatic Cohort Participants with metastatic pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
Overall Study Adverse Event	1	2
Overall Study Disease progression	5	16
Overall Study Participant withdrew consent	2	1

Baseline Characteristics

MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Measure	Locally Advanced Cohort n=8 Participants Participants with locally advanced pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.	Metastatic Cohort n=19 Participants Participants with metastatic pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.	Total n=27 Participants Total of all reporting groups
Age, Continuous	58.3 Years STANDARD_DEVIATION 6.48 • n=5 Participants	51.5 Years STANDARD_DEVIATION 9.81 • n=7 Participants	53.5 Years STANDARD_DEVIATION 9.36 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	18 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose to 3 weeks following the end of the treatment cycle, up to 24 weeks.

Population: All treated participants

Percentage of participants who achieved Complete Response (CR) or Partial Response (PR) according to RECIST criteria. Particularly, CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease n the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

Outcome measures

Measure	Locally Advanced Cohort n=8 Participants Participants with locally advanced pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.	Metastatic Cohort n=19 Participants Participants with metastatic pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)	0 Percent of Participants	0 Percent of Participants

Adverse Events

Ipilimumab 3 mg/Kg

Serious events: 20 serious events

Other events: 26 other events

Deaths: 12 deaths

Serious adverse events

Measure	Ipilimumab 3 mg/Kg n=27 participants at risk Participants with locally advanced or metastatic pancreatic adenocarcinoma treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
Blood and lymphatic system disorders Anaemia	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Blood and lymphatic system disorders Lymphopenia	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Endocrine disorders Hypophysitis	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Abdominal pain	22.2% 6/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Ascites	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Colitis	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Diarrhoea	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Duodenal obstruction	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Intestinal ischaemia	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Jejunal ulcer	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Obstruction gastric	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Vomiting	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
General disorders Fatigue	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Hepatobiliary disorders Bile duct obstruction	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Hepatobiliary disorders Cholangitis	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Hepatobiliary disorders Hyperbilirubinaemia	11.1% 3/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Hepatobiliary disorders Liver disorder	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Infections and infestations Infection	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Infections and infestations Sepsis	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Infections and infestations Sinusitis	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Infections and infestations Urinary tract infection	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Injury, poisoning and procedural complications Post procedural bile leak	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Alanine aminotransferase increased	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Aspartate aminotransferase increased	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Blood alkaline phosphatase increased	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Blood amylase increased	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Blood bilirubin increased	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Lipase increased	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Metabolism and nutrition disorders Dehydration	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Metabolism and nutrition disorders Hypoalbuminaemia	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Metabolism and nutrition disorders Hypokalaemia	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Nervous system disorders Cerebral ischaemia	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Nervous system disorders Embolic cerebral infarction	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Psychiatric disorders Confusional state	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.7% 1/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Vascular disorders Deep vein thrombosis	11.1% 3/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).

Other adverse events

Measure	Ipilimumab 3 mg/Kg n=27 participants at risk Participants with locally advanced or metastatic pancreatic adenocarcinoma treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
Blood and lymphatic system disorders Lymphopenia	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Abdominal distension	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Abdominal pain	22.2% 6/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Ascites	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Constipation	29.6% 8/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Diarrhoea	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Flatulence	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Melaena	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Nausea	33.3% 9/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Gastrointestinal disorders Vomiting	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
General disorders Chills	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
General disorders Fatigue	48.1% 13/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
General disorders Oedema	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
General disorders Oedema peripheral	18.5% 5/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
General disorders Pyrexia	40.7% 11/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Hepatobiliary disorders Hyperbilirubinaemia	18.5% 5/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Infections and infestations Oral candidiasis	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Alanine aminotransferase increased	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Aspartate aminotransferase increased	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Blood alkaline phosphatase increased	22.2% 6/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Haemoglobin decreased	11.1% 3/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Weight decreased	51.9% 14/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Investigations Weight increased	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Metabolism and nutrition disorders Anorexia	18.5% 5/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Metabolism and nutrition disorders Dehydration	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Metabolism and nutrition disorders Hypoalbuminaemia	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Metabolism and nutrition disorders Hypokalaemia	11.1% 3/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Metabolism and nutrition disorders Hypomagnesaemia	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Musculoskeletal and connective tissue disorders Back pain	22.2% 6/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Nervous system disorders Headache	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Psychiatric disorders Confusional state	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Psychiatric disorders Insomnia	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Respiratory, thoracic and mediastinal disorders Cough	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Respiratory, thoracic and mediastinal disorders Dyspnoea	22.2% 6/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Skin and subcutaneous tissue disorders Pruritus	11.1% 3/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Skin and subcutaneous tissue disorders Rash	22.2% 6/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Vascular disorders Hypertension	7.4% 2/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).
Vascular disorders Hypotension	14.8% 4/27 • All Adverse Events were collected from first dose to study completion (up to approximately 1 year) Adverse Events were not monitored/assessed by disease status separately because both cohorts (Locally Advanced cohort and Metastatic cohort) received the same treatment at the same dose. Hence, Adverse Events are reported as a single cohort (Ipilimumab 3 mg/Kg).

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER