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Pancreatic CancerPhase 1NCT02868632

Study of Immune Checkpoint Inhibition With Radiation Therapy in Unresectable, Non-metastatic Pancreatic Cancer

A Phase 1 study testing MEDI4736, Tremelimumab and Stereotactic Body Radiation Therapy (SBRT) in people with Pancreatic Cancer, run by NYU Langone Health at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an open-label, three-cohort, phase Ib study to determine the safety, recommended phase 2 dose (RP2D), and efficacy of Stereotactic Body Radiation Therapy (SBRT) in combination with either (A) MEDI4736 alone, (B) tremelimumab alone, or (C) the combination of MEDI4736 and tremelimumab for patients with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
MEDI4736, Tremelimumab and Stereotactic Body Radiation Therapy (SBRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
7 Aug 2016to 4 Mar 2019
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histopathological confirmation of pancreatic adenocarcinoma prior to study entry.
  • Unresectable and non-metastatic disease
  • At least 1 measurable metastatic lesion by RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques, or as >10 mm with spiral computed tomography (CT) scan, and that is accessible for biopsy.
  • Age >18 years
  • ECOG performance status 0-1
  • Normal organ and marrow function as defined below:
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  • Absolute Neutrophil Count > 1,000/mcL Platelets ≥ 75,000/mcL Total Bilirubin ≤ 2 x ULN Serum Albumin ≥ 2.5 g/dl ALT or AST up to 3 x ULN if no liver metastases or ALT or AST up to 5 x ULN if liver metastases present Creatinine < 2 x institution upper limit of normal OR Creatinine Clearance > 45 mL/min/1.73 m2, as calculated below, for patients with creatinine levels above institutional normal
  • No history of another malignancy in the past 5 years, except for treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma-in-situ of the cervix
  • No coexisting medical problems that would limit compliance with the study
  • Ability to understand and sign a written informed consent document. Patient must have willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
  • Female subjects of childbearing potential must have a negative serum pregnancy test prior to study entry
  • Female subjects of childbearing potential and males must agree to use a highly effective method of contraception for the duration of study treatment, and for six months after discontinuation of the study drug.

Who cannot join

  • Resectable, borderline resectable or metastatic disease
  • Prior chemotherapy, targeted therapy, immunotherapy, clinical trials or radiotherapy for pancreatic cancer.
  • Active or history of concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens, immunosuppressive agents, other investigational therapies, or chronic use of systemic corticosteroids (inhaled and topical steroids are permitted)
  • Active or history of chronic autoimmune disease with symptomatic disease within the 3 years before randomization.
  • Active or history of inflammatory bowel disease (colitis, Crohn's disease), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea.
  • Diverticulitis within the past 2 years.
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  • Active HIV infection
  • Uncontrolled systemic disease including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Brain metastases
  • Patients should not be vaccinated with live attenuated vaccines within 1 month of starting tremelimumab and MEDI4736 treatment.
  • History of hypersensitivity reaction to human or mouse antibody products
  • Evidence of pre-existing idiopathic pulmonary fibrosis on CT scan at baseline
  • Unhealed surgical wound at time of treatment, or history of unhealed surgical wound for more than 30 days
  • History of an invasive secondary primary malignancy diagnosed within the previous 3 years, except for appropriately treated stage I endometrial or cervical carcinoma, prostate carcinoma treated surgically or non-melanoma skin cancer.
  • Non-protocol antineoplastic agents will not be permitted during this study
  • Patients may not recieve other investigational agents.
  • Pregnant or lactating women
  • Subjects with dementia or significantly altered mental status that would prohibit understanding or rendering of information and consent and compliance with the requirements of the protocol.
  • Subjects unable or unwilling to abide by the study protocol or cooperate fully.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • New York University School of Medicine

    New York, New York, 10016

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase I Study of Immune Checkpoint Inhibition (Anti-CTLA4 and/or Anti-PD-L1) in Combination With Radiation Therapy in Patients With Unresectable and Non-metastatic Pancreatic Cancer

This is an open-label, three-cohort, phase Ib study to determine the safety, recommended phase 2 dose (RP2D), and efficacy of Stereotactic Body Radiation Therapy (SBRT) in combination with either (A) MEDI4736 alone, (B) tremelimumab alone, or (C) the combination of MEDI4736 and tremelimumab for patients with unresectable locally advanced adenocarcinoma of pancreas.

Read the detailed description

Patients with unresectable, locally advanced adenocarcinoma of pancreas will receive Stereotactic Body Radiation Therapy (SBRT) at a dose of 6 Gy daily, for 5 days. In Cohort A, where MEDI4736 is given, subjects will receive 10 mg/kg of MEDI4736 every 2 weeks, on the same day as, but after the first dose of SBRT is delivered (within 4 hours). In Cohort B, where tremelimumab is given, subjects will receive 10 mg/kg of tremelimumab every 4 weeks, on the same day as, but after the first dose of SBRT is delivered (within 4 hours). In Cohort C, where MEDI4736 and tremelimumab are given in combination, subjects will receive 10 mg/kg of tremelimumab every 4 weeks, on the same day as, but after the first dose of SBRT is delivered (within 4 hours), followed by 10 mg/kg of MEDI4736 every 4 weeks.

Correlative Studies The investigators will evaluate immune changes in peripheral blood samples and in tumor biopsy fine needle aspirate (FNA) specimens pre- and post- treatment from the 3 cohorts that involve the combination of stereotactic body radiation therapy (SBRT) with either (A) MEDI4736 alone, (B) tremelimumab alone, or (C) the combination of MEDI4736 and tremelimumab. FNA biopsies will be done at baseline (within 30 days of treatment initiation) and Day 28 of cycle 2 (between days 22-28 of cycle 2).

Being tested
MEDI4736, Tremelimumab, Stereotactic Body Radiation Therapy (SBRT)
Keywords
Unresectable, Locally Advanced, Non-Metastatic
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDI4736Drug

    Also called Durvalumab

    anti-PD-L1 human monoclonal antibody

  • TremelimumabDrug

    Also called CP-675,206

    anti-CTLA4 human monoclonal antibody

  • Stereotactic Body Radiation Therapy (SBRT)Radiation

    Stereotactic body radiation therapy (SBRT) will be administered at the standard dose of 6 Gy daily for 5 days.

Study groups in NCT02868632
Study groupRoleWhat they receive
Cohort A: MEDI4736 + SBRTExperimentalMEDI4736 10 mg/kg IV every 2 weeks plus Stereotactic Body Radiation (SBRT) 6 Gy x 5 Days, 10 Subjects
Receives: Drug: MEDI4736; Radiation: Stereotactic Body Radiation Therapy (SBRT)
Cohort B:Tremelimumab + SBRTExperimentalTremelimumab 10 mg/kg IV every 4 weeks plus Stereotactic Body Radiation (SBRT) 6 Gy x 5 Days, 10 Subjects
Receives: Drug: Tremelimumab; Radiation: Stereotactic Body Radiation Therapy (SBRT)
Cohort C: MEDI4736 + Tremelimumab + SBRTExperimentalMEDI4736 + Tremelimumab (recommended phase 2 IV dose for combination) plus Stereotactic Body Radiation (SBRT) 6 Gy x 5 Days, 16 Subjects
Receives: Drug: MEDI4736; Drug: Tremelimumab; Radiation: Stereotactic Body Radiation Therapy (SBRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Kaplan Meier curves will be used to summarize Overall Survival.

    Measured: 24 Months

Secondary outcomes (3)

  1. Progression-Free Survival

    Kaplan Meier curves will be used to summarize Progression-Free Survival.

    Measured: 24 Months

  2. Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Response rates will be estimated with exact 95% confidence intervals for each dose level.

    Measured: 24 Months

  3. Immune-related Response Criteria (irRC)

    Kaplan Meier curves will be used to summarize Clinical Benefit Rate.

    Measured: 24 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study start7 Aug 2016
  3. Primary completion4 Mar 2019
  4. Study completion4 Mar 2019

Why it stopped: termination because of low accrual; four subjects enrolled and four screen failures.

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02868632
Sponsor's protocol ID
14-01317
Status last verified
Apr 2019
First submitted
8 Aug 2016
Last updated
5 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEDI4736, Tremelimumab and Stereotactic Body Radiation Therapy (SBRT) in people with Pancreatic Cancer, run by NYU Langone Health 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 12 inclusion and 19 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: withdrawn, as of the sponsor's last update on 5 Apr 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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 Survival (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02868632.

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 5 Apr 2019.

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