Study Summary
This trial is being conducted to study the efficacy of the ipilimumab, nivolumab, and radiation therapy in microsatellite stable pancreatic cancer patients.
Eligible Conditions
- Pancreatic Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Up to 5 years
6 weeks
Overall response rate (ORR)
Up to 5 years
Number of Participants with Treatment Related Adverse Events as Assessed NCI CTCAE 5.0 guidelines
Overall survival (OS) in patients
Progression-free survival (PFS)
Up to 5 yrs
Disease control rate (DCR)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
38%Alopecia
36%Anaemia
32%Nausea
31%Decreased appetite
31%Diarrhoea
30%Fatigue
25%Constipation
23%Neutropenia
20%Dyspnoea
19%Pyrexia
19%Vomiting
18%Rash
17%Cough
17%Asthenia
16%Arthralgia
16%Pruritus
16%Thrombocytopenia
15%Peripheral sensory neuropathy
14%Myalgia
13%Neuropathy peripheral
13%Insomnia
11%Hypokalaemia
10%Platelet count decreased
9%Pain in extremity
9%Leukopenia
9%Weight decreased
8%Hyponatraemia
8%Pneumonia
8%Alanine aminotransferase increased
8%Haemoglobin decreased
7%Malignant neoplasm progression
7%Back pain
7%Neutrophil count decreased
7%Aspartate aminotransferase increased
7%Dizziness
7%Bone pain
7%Haemoptysis
6%Hypomagnesaemia
6%Stomatitis
6%Headache
5%Abdominal pain
5%Oedema peripheral
5%Chest pain
5%Abdominal pain upper
5%White blood cell count decreased
5%Dehydration
4%Musculoskeletal pain
4%Febrile neutropenia
4%Paraesthesia
3%Colitis
2%Lung infection
2%Pulmonary embolism
2%Death
2%Mucosal inflammation
1%Pneumothorax
1%Interstitial lung disease
1%Cardio-respiratory arrest
1%Chronic obstructive pulmonary disease
1%Pulmonary haemorrhage
1%Urinary tract infection
1%Confusional state
1%Drug hypersensitivity
1%Cerebrovascular accident
1%Lung abscess
1%Multi-organ failure
1%Blood creatinine increased
1%Metastases to central nervous system
1%Atrial fibrillation
1%Disease progression
1%Renal failure
1%Liver function test abnormal
1%Lower respiratory tract infection
1%Lung neoplasm malignant
1%Pain
1%Acute kidney injury
1%Hypersensitivity
1%General physical health deterioration
1%Intestinal perforation
1%Infection
1%Pneumonitis
1%Respiratory failure
1%Syncope
1%Hyperglycaemia
1%Sudden death
1%Sepsis
Trial Design
1 Treatment Group
Nivolumab + Ipilimumab + Radiation
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Ipilimumab · No Placebo Group · Phase 2
Nivolumab + Ipilimumab + RadiationExperimental Group · 3 Interventions: Nivolumab, Ipilimumab, Radiation · Intervention Types: Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved
Radiation
2005
Completed Phase 3
~970
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,705 Previous Clinical Trials
30,853,851 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,501 Previous Clinical Trials
3,928,146 Total Patients Enrolled
Theodore S Hong, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
166 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have histologically or cytologically confirmed metastatic MSS adenocarcinoma of pancreatic origin.
You have a white blood count (WBC) of at least 2000 /mcL.
Platelets ≥75,000 / microliter.
The absolute neutrophil count (ANC) is greater than or equal to 1000 per microliter.
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Conditions
Cancer Related
Treatments