Pancreatic CancerPhase 2NCT04361162
Nivolumab + Ipilimumab + Radiation in MSS Pancreatic Cancer
A Phase 2 study testing Nivolumab, Ipilimumab and Radiation in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
This research is being done to study the effects of the combination of ipilimumab, nivolumab, and radiation therapy in people with microsatellite stable pancreatic cancer. The names of the study interventions involved in this study are: Ipilimumab Nivolumab Radiation Therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- Nivolumab, Ipilimumab and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 May 2020to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically or cytologically confirmed metastatic MSS adenocarcinoma of pancreatic origin
- Age >18 years.
- ECOG performance status <2
- Life expectancy of greater than 3 months
- Participants must have normal organ and marrow function as defined in Table 1, all screening labs should be performed within 14 days of protocol registration.
- Hematological
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- Absolute neutrophil count(ANC) ≥1000 /mcL
- White blood count (WBC) ≥2000 /mcL
- Platelets ≥75,000 / mcL
- Hemoglobin ≥7.5 g/dL
- Renal
- Serum creatinine: ≤ Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) OR
- Measured or calculated Creatinine clearance should be calculated per institutional standard: ≥ 40 mL/min (if using the Cockcroft-Gault formula below):
- (GFR can also be used in place of creatinine or CrCl)
- Female CrCl = (140 - age in years) x weight in kg x 0.85/ 72 x serum creatinine in mg/dL
- Male CrCl = (140 - age in years) x weight in kg x 1.00/ 72 x serum creatinine in mg/dL
- Hepatic
- Serum total bilirubin ≤ 1.5 X ULN (subjects with Gilbert Syndrome can have a total bilirubin <3 mg/dL
- AST (SGOT) and ALT (SGPT) ≤ 3 X ULN OR ≤ 5 X ULN for subjects with liver metastases
- Coagulation
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants
- Activated Partial Thromboplastin Time (aPTT) ≤2.5 X ULN unless subject is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants
- Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
- Women must not be breastfeeding
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women who are not of childbearing potential, ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception
- Ability to understand and the willingness to sign a written informed consent document.
- If applicable, stable dose of dexamethasone 1.5mg or prednisone <10mg for 7 days prior to initiation of treatment
- One previously unirradiated lesion amenable to radiotherapy 8 Gy x 3 and can meet dose constraints, and another unirradiated measurable lesion > 1 cm in size outside the radiation field that can be used as measurable disease. (Patients must have measurable tumor in addition to the one being radiated.)
- Patients must have progressed on at least 1 prior line of chemotherapy. Adjuvant or neoadjuvant therapy is permitted
Who cannot join
- Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days of protocol treatment, or those who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Participants who are receiving any other investigational agents.
- Patients are excluded if they have an active, known or suspected autoimmune disease other than those listed below. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
- Patients are excluded if they have a condition requiring systemic treatment with either corticosteroids (dexamethasone 1.5mg or prednisone <10mg) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses dexamethasone 1.5mg or prednisone <10mg are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, dexamethasone 1.5mg or prednisone <10mg. A brief course of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
- Patients are excluded if they have previously received anti-CTLA-4 therapy. Prior PD-1 or PDL1 therapy will be permitted.
- Has a known history of active TB (Bacillus Tuberculosis)
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- Known HBV or HCV. (Patients are excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection).
- Patients are excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).These participants are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months for woman and 7 months for men, after the last dose of trial treatment.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has received a live vaccine within 30 days of planned start of study therapy.Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- History of allergy to study drug components
- History of severe hypersensitivity reaction to any monoclonal antibody
- Uncontrolled brain metastases. Patients treated with radiation > 4 weeks prior with follow up imaging showing control are eligible
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Nivolumab and Ipilimumab and Radiation Therapy in Metastatic, Microsatellite Stable Pancreatic Cancer
This research is being done to study the effects of the combination of ipilimumab, nivolumab, and radiation therapy in people with microsatellite stable pancreatic cancer.
The names of the study interventions involved in this study are:
- Ipilimumab
- Nivolumab
- Radiation Therapy
Read the detailed description
This research study is a Phase II clinical trial study testing the safety and effectiveness of the combination of ipilimumab, nivolumab, and radiation therapy.
The research study procedures include screening for eligibility, and study treatment including evaluations and follow up visits.
Participants will be in this research study for as long as the study interventions are safe and beneficial. Participants will then be followed for up to 5 years.
The names of the study interventions involved in this study are:
- Ipilimumab
- Nivolumab
- Radiation Therapy It is expected that about 30 people will take part in this research study.
Ipilimumab and Nivolumab are both antibodies. An antibody is a protein that attaches to other cells to fight off infection. The antibodies in ipilimumab work by not allowing cancer cell growth. The antibodies in nivolumab work by causing programmed cell death of the cancer cells. Radiation therapy may increase the likelihood of response to interventions like ipilimumab and nivolumab.
The U.S. Food and Drug Administration (FDA) has not approved ipilimumab and nivolumab for microsatellite stable pancreatic cancer. but they have been approved for other uses.
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Being tested
- Nivolumab, Ipilimumab, Radiation
- Keywords
- Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic, Microsatellite Stable Pancreatic Cancer, Immunotherapy, Radiation therapy
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
IpilimumabDrug
Also called Yervoy
Ipilimumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Ipilimumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
RadiationRadiation
Also called RT
3D Conformal Radiotherapy to shrink or kill tumors
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab + Ipilimumab + Radiation | Experimental | 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. Receives: Drug: Nivolumab; Drug: Ipilimumab; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Overall response rate (ORR) will be evaluated by RECIST. Nivolumab and ipilimumab combined with radiation will be considered to have promising activity in metastatic MSS pancreatic cancer if at least 3 of 30 patients were to achieve CR or PR.
Measured: 6 weeks
Secondary outcomes (4)
Disease control rate (DCR)
Disease control rate (DCR) will be based on RECIST and estimated with 95% confidence intervals based on the exact binomial distribution.
Measured: Up to 5 yrs
Number of Participants with Treatment Related Adverse Events as Assessed NCI CTCAE 5.0 guidelines
Toxicity rates associated with the protocol treatment of nivolumab and ipilimumab combined with radiation will be summarized by category and grade.
Measured: Up to 5 years
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the duration from the first day of protocol treatment to the earliest date of tumor progression by RECIST, appearance of new metastases, or death due to any cause. PFS time will be censored at the date of last follow-up for patients still alive with disease control. The PFS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
Measured: Up to 5 years
Overall survival (OS) in patients
Overall survival (OS) is defined as the duration from the first day of protocol treatment to the date of death due to any cause and will be censored at the date of last follow-up for patients still alive. The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start18 May 2020
- Primary completionOct 2022 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Theodore Sunki Hong, Massachusetts General Hospital
- Investigators
- Theodore S Hong, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361162
- Sponsor's protocol ID
- 19-587
- Status last verified
- Sep 2022
- First submitted
- 22 Apr 2020
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab and Ipilimumab and Radiation Therapy in Metastatic, Microsatellite Stable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04361162
- Acronym / sponsor ID
- 19-587
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic, Microsatellite Stable Pancreatic Cancer, Immunotherapy, Radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 18 May 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to study the effects of the combination of ipilimumab, nivolumab, and radiation therapy in people with microsatellite stable pancreatic cancer.
The names of the study interventions involved in this study are:
- Ipilimumab
- Nivolumab
- Radiation Therapy
Detailed description
This research study is a Phase II clinical trial study testing the safety and effectiveness of the combination of ipilimumab, nivolumab, and radiation therapy.
The research study procedures include screening for eligibility, and study treatment including evaluations and follow up visits.
Participants will be in this research study for as long as the study interventions are safe and beneficial. Participants will then be followed for up to 5 years.
The names of the study interventions involved in this study are:
- Ipilimumab
- Nivolumab
- Radiation Therapy It is expected that about 30 people will take part in this research study.
Ipilimumab and Nivolumab are both antibodies. An antibody is a protein that attaches to other cells to fight off infection. The antibodies in ipilimumab work by not allowing cancer cell growth. The antibodies in nivolumab work by causing programmed cell death of the cancer cells. Radiation therapy may increase the likelihood of response to interventions like ipilimumab and nivolumab.
The U.S. Food and Drug Administration (FDA) has not approved ipilimumab and nivolumab for microsatellite stable pancreatic cancer. but they have been approved for other uses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab + Ipilimumab + Radiation | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Radiation: RadiationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Participants must have histologically or cytologically confirmed metastatic MSS adenocarcinoma of pancreatic origin
- Age >18 years.
- ECOG performance status <2
- Life expectancy of greater than 3 months
- Participants must have normal organ and marrow function as defined in Table 1, all screening labs should be performed within 14 days of protocol registration.
Key exclusion criteria (18 listed)
- Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days of protocol treatment, or those who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Participants who are receiving any other investigational agents.
- Patients are excluded if they have an active, known or suspected autoimmune disease other than those listed below. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
- Patients are excluded if they have a condition requiring systemic treatment with either corticosteroids (dexamethasone 1.5mg or prednisone <10mg) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses dexamethasone 1.5mg or prednisone <10mg are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, dexamethasone 1.5mg or prednisone <10mg. A brief course of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
- Patients are excluded if they have previously received anti-CTLA-4 therapy. Prior PD-1 or PDL1 therapy will be permitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: OpdivoNivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer | Drug | Nivolumab + Ipilimumab + Radiation |
| IpilimumabAlso: YervoyIpilimumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Ipilimumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer | Drug | Nivolumab + Ipilimumab + Radiation |
| RadiationAlso: RT3D Conformal Radiotherapy to shrink or kill tumors | Radiation | Nivolumab + Ipilimumab + Radiation |
Primary outcome
Overall response rate (ORR)
Time frame: 6 weeks
Overall response rate (ORR) will be evaluated by RECIST. Nivolumab and ipilimumab combined with radiation will be considered to have promising activity in metastatic MSS pancreatic cancer if at least 3 of 30 patients were to achieve CR or PR.
4 secondary outcomes
Disease control rate (DCR)
Time frame: Up to 5 yrs
Number of Participants with Treatment Related Adverse Events as Assessed NCI CTCAE 5.0 guidelines
Time frame: Up to 5 years
Progression-free survival (PFS)
Time frame: Up to 5 years
Overall survival (OS) in patients
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore S Hong, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Ipilimumab and Radiation in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.