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Checkpoint Inhibitor

Nivolumab + Ipilimumab + Radiation for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Theodore S Hong, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status <2
Participants must have histologically or cytologically confirmed metastatic MSS adenocarcinoma of pancreatic origin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is being conducted to study the efficacy of the ipilimumab, nivolumab, and radiation therapy in microsatellite stable pancreatic cancer patients.

Who is the study for?
This trial is for adults over 18 with metastatic MSS pancreatic cancer who have had at least one prior chemotherapy treatment. They must be in good health otherwise, with proper organ and marrow function, and a life expectancy of more than 3 months. Participants need to have tumors suitable for radiation therapy and measurable disease outside the radiation field.Check my eligibility
What is being tested?
The study tests a combination of two immunotherapy drugs, Nivolumab and Ipilimumab, along with Radiation Therapy on patients with microsatellite stable (MSS) pancreatic cancer to see how effective this trio is against the disease.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs like the liver or lungs, skin rash, hormone gland problems (like thyroid), infusion-related reactions during drug administration, fatigue, nausea, and potential increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most of my daily activities without help.
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My cancer is a type of pancreatic cancer that has spread and is not MSI-High.
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I am older than 18 years.
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I have been on a stable dose of dexamethasone or prednisone for the last week.
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I have at least two tumors, one that can be treated with radiation and another that can be measured and is outside the radiation area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Disease control rate (DCR)
Number of Participants with Treatment Related Adverse Events as Assessed NCI CTCAE 5.0 guidelines
Overall survival (OS) in patients
+1 more

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung neoplasm malignant
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nivolumab + Ipilimumab + RadiationExperimental Treatment3 Interventions
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, (Study cycles are 6 weeks.) Nivolumab via iv, at predetermined dose every 2 weeks for duration of study. Ipilimumab via iv at a predetermined dose on day 1 of 4 study cycles. Radiation treatments will be administered every other weekday or 2 days during week 1 of cycle 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved
Radiation
2003
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,415 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,002 Total Patients Enrolled
Theodore S Hong, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
159 Total Patients Enrolled

Media Library

Pancreatic Cancer Research Study Groups: Nivolumab + Ipilimumab + Radiation
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04361162 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the prior results of investigations utilizing Ipilimumab?

"Presently, 765 trials are underway researching Ipilimumab. Of those live studies, 86 are in the third phase of testing. Most of these investigations about this treatment take place near Pittsburg, Pennsylvania; however there is an extensive network of trial sites numbering upwards to 42,707 locations across the world."

Answered by AI

Are recruitment efforts still in progress for this trial?

"Unfortunately, clinicaltrials.gov data reveals that this trial is not presently open for recruitment. Initially posted on May 18th 2020 and last edited on September 7th 2022, the trial has temporarily ceased to entertain applicants; however there are 1,469 other trials actively recruiting participants at present."

Answered by AI

What common maladies can be alleviated with Ipilimumab?

"Ipilimumab is used to treat ailments following anti-angiogenic therapy, and can be useful for the management of malignant neoplasms, unresectable melanoma, and squamous cell carcinomas."

Answered by AI

What risks do patients face when using Ipilimumab as a treatment?

"Our experts at Power deemed Ipilimumab to be relatively safe, awarding it a score of 2. This originates from the Phase 2 trial data that partially supports its safety but does not provide any evidence for efficacy."

Answered by AI

How many participants are engaged in this research initiative?

"At this time, this research project is no longer recruiting any more participants. It was initially posted in May 18th 2020 and most recently modified on September 7th 2022. Those seeking alternative trials can look to the currently ongoing studies: there are 704 trials searching for patients with pancreas cancer and another 765 inviting individuals to take part in ipilimumab research."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab + Ipilimumab + Radiation in MSS Pancreatic Cancer
Theodore Sunki Hong 2020. "Nivolumab + Ipilimumab + Radiation in MSS Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04361162.
~6 spots leftby Apr 2025
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