Ipilimumab for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pancreatic Cancer+1 MoreIpilimumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT01285609) in the 10 MG/KG Ipilimumab + Paclitaxel/ Carbop ARM group. Side effects include: Alopecia with 38%, Anaemia with 36%, Nausea with 32%, Decreased appetite with 31%, Diarrhoea with 31%.

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.