M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas

Stopped early · Phase 1/Phase 2

Conditions studied: Cancer of Pancreas, Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Cancer, Pancreatic Neoplasms

In brief

Background: Pancreas cancer ranks 4th in all cancer-related deaths in the United States (U.S.) Gemcitabine is a standard treatment for it. M7824 (MSB0011359C) blocks a pathway that prevents the immune system from effectively fighting cancer. The two drugs together might help people with pancreas cancer. Objective: To test if giving M7824 together with gemcitabine is safe and causes tumors to shrink. Eligibility: People ages 18 and older with pancreatic cancer already treated with standard therapies Design: Participants will be screened with: Medical history Physical exam Scans in a machine that takes pictures of the body Blood, urine, and heart tests Some participants may have a tumor sample removed. Participants will get M7824 by intravenous (IV) once every 2 weeks. They will continue until their disease gets worse or they have unacceptable side effects. After the first dose, participants will also get gemcitabine by IV once weekly for 7 weeks. Then they will get it as follows for up to 6 months: Skip 1 week, get the drug once a week for 3 weeks, skip 1 week. Before treatment on the first day of each cycle, participants will repeat screening tests. They will also have: Optional tumor biopsies before and after 3 cycles of therapy Questions about their well-being and function Genetic testing of tissue and blood samples Participants will have a follow-up visit 4-5 weeks after they stop therapy. This includes a physical exam, blood and urine tests, and maybe a scan. If their disease does not get worse, they will be invited for scans every 12 weeks.

Key facts

Study ID

NCT03451773

Run by

National Cancer Institute (NCI)

People needed

7

Starts

2018-05-17

Expected to finish

2020-05-05

Last updated by the study team

2021-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who are receiving any other investigational agents
• Prior therapy with any antibody / drug targeting T cell coregulatory proteins (immune checkpoints) such as anti-Programmed cell death protein 1 (PD-1), anti-Programmed death-ligand 1 (PD-L1), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody.
• Anticancer treatment within designated period before enrollment including:
• minor surgical procedure (such as biliary stenting) within 14 days
• major surgical procedure or radiation treatment within 28 days
• chemotherapy or experimental drug treatment with published half-life known to be 72 hours within 14 days
• experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days
• radiotherapy for measurable lesions delivered in a normal organ-sparing technique within 21 days (except for palliative radiotherapy)
• Concurrent treatment with non-permitted drugs including herbal remedies with immunostimulating properties (for example, mistletoe extract) or known to potentially interfere with major organ function (for example, hypericin).
• Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with a history of cervical carcinoma in situ, superficial or no-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.
• Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.
• Subjects with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded. Subjects with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 2 months, and do not require continued steroid therapy. Subjects with CNS metastases incidentally detected during Screening which do not cause clinical symptoms and for which standard of care suggests no therapeutic intervention is needed are eligible.
• Receipt of any organ transplantation, including allogeneic stem-cell transplantation, except of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant)
• Significant acute or chronic infections including tuberculosis (history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings)
• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent with the exceptions:
• diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;
• subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses less than or equal to 10 mg of prednisone or equivalent per day;
• administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is acceptable.
• Known severe hypersensitivity reactions to monoclonal antibodies (Grade greater than or equal to 3 National Cancer Institute Common Terminology Criteria in Adverse Events (NCI-CTCAE) v4.03, any history of anaphylaxis or history of uncontrolled asthma.
• Known severe hypersensitivity to gemcitabine.
• Female patients who are pregnant or breastfeeding. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M7824 in combination with gemcitabine, breastfeeding should be discontinued.
• Known alcohol or drug abuse.
• Clinically significant cardiovascular / cerebrovascular disease as follows: cerebral vascular accident / stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class greater than or equal to II), or serious cardiac arrhythmia.
• Clinically relevant diseases (for example, inflammatory bowel disease) and/or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.
• Vaccine administration of live vaccines within 28 days of enrollment.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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