A Study of MEDI9197 in Subjects With Solid Tumors or CTCL and in Combination With Durvalumab and/or Palliative Radiation in Subjects With Solid Tumors

Stopped early · Phase 1

Conditions studied: Solid Tumors, CTCL, Cancer

In brief

To evaluate MEDI9197 when administered by intratumoral injection to subjects with solid tumors and in combination with durvalumab in subjects with solid tumors.

Key facts

Study ID

NCT02556463

Run by

MedImmune LLC

People needed

53

Starts

2015-11-04

Expected to finish

2018-10-26

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Any of the following would exclude the subject from participation in the study:
• Subjects who have received prior immunotherapy [(including but not limited to CTLA-4, oncolytic virus, oncolytic peptide-all require 100 day washout), programmed death ligand (PDL)-1, or programmed cell death 1 antagonists-both require 14 day washout)] are NOT permitted to enroll, with protocol exceptions.
• Pregnant or lactating.
• Active bacterial, fungal, or viral infections, including chronic or active hepatitis B, chronic or active hepatitis C, or active hepatitis A. Prior documented infections must have resolved.
• Active or prior documented autoimmune or inflammatory disorders, with exceptions per protocol. Includes known allergy to sesame oil and/or nuts.
• Immune-deficiency states - myelodysplastic disorders, marrow failures, human immunodeficiency virus (HIV) infection, history of solid organ transplant or bone marrow allograft, or recent pregnancy.
• Requires continuous (daily) anticoagulation or antiplatelet therapy (including anti aggregants), acetylsalicylic acid (ASA) or nonsteroidal anti-inflammatory drugs (NSAIDs).
• History of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
• Rapidly progressing disease per protocol.
• Untreated or uncontrolled central nervous system (CNS) involvement.
• Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment; with exceptions per protocol.
• Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, with exception of alopecia, vitiligo.
• Uncontrolled concurrent illness.
• Cardiac exclusions: New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled hypertension, acute coronary syndrome within 6 months, clinical important cardiac arrhythmia, mean QTC interval corrected for heart rate >500ms.
• Major surgery within 4 weeks prior to study entry or still recovering from prior surgery.
• Receipt of live, attenuated vaccine within 28 days prior to study entry.
• Receipt of any systemic anticancer therapy not mentioned above within the last 2 weeks or 5 half-lives.
• Cognitive disorder such that informed consent cannot be obtained directly from the subject
• Subjects who have previously participated in this study and received MEDI9197, or concurrent enrollment in another clinical study involving an investigational treatment.
• Subjects who have received prior TLR agonists, both systemic and topical.
• Patients who have received prior therapeutic radiation within 28 days of dosing. All toxicities from prior radiotherapy must have resolved to ≤ Grade 1 or baseline prior to dosing.
• Body weight < 35 kg
• Subjects enrolling in Part 3 (ie, receiving durvalumab) must not have a history of interstitial lung disease or pneumonitis.

Where it is running

• Research Site — San Francisco, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — New York, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Houston, Texas, United States
• Research Site — Toronto, Ontario, Canada
• Research Site — Villejuif, France

Full record on ClinicalTrials.gov

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