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BRIEF TITLE: Study of In Situ Vaccination With Tremelimumab and IV Durvalumab (MEDI4736) Plus the Toll-like Receptor Agonist PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers

A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab (MEDI4736) Plus the Toll-like Receptor Agonist PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers


  • Org Study ID: LUD2014-011
  • Secondary ID:
  • NCT ID: NCT02643303
  • NCT Alias:
  • Sponsor: Ludwig Institute for Cancer Research - Other
  • Source: Ludwig Institute for Cancer Research

Brief Summary

This is an open-label, multicenter Phase 1/2 study of the CTLA-4 antibody, tremelimumab, and the PD-L1 antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment (TME) modulator polyICLC, a TLR3 agonist, in subjects with advanced, measurable, biopsy-accessible cancers.

Overal Status Start Date Phase Study Type
Recruiting December 28, 2016 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Progression-Free Survival (PFS) at 24 weeks

Primary Outcome 1 - Time Frame: up to 24 weeks

Condition:

  • Head and Neck Squamous Cell Carcinoma
  • Breast Cancer
  • Sarcoma
  • Merkel Cell Carcinoma
  • Cutaneous T-Cell Lymphoma
  • Melanoma
  • Renal Cancer
  • Bladder Cancer
  • Prostate Cancer
  • Testicular Cancer
  • Solid Tumor

Eligibility

Criteria:
Inclusion Criteria:

1. Subjects must have histologic confirmation of advanced, biopsy-accessible, measurable
cancers of the following histologies:

- Non-viral-associated head and neck squamous cell carcinoma (HNSCC) or
HPV-associated HNSCC after failure of prior therapy

- Locally recurrent or metastatic breast cancer

- Sarcoma

- Merkel Cell Carcinoma (MCC)

- Cutaneous T cell Lymphoma (CTCL)

- Melanoma after failure of available therapies

- GU cancers with accessible metastases (e.g., bladder, renal)

- Any solid tumors with masses that are accessible

2. Subjects with measurable disease, must have at least 2 lesions (1 measurable lesion
and 1 biopsy/injectable lesion, which will not need to be measurable).

3. Any number of prior systemic therapies.

4. ECOG performance status 0-1.

5. Laboratory parameters for vital functions should be in the normal range or not
clinically significant.

Exclusion Criteria:

1. Prior treatment with combination CTLA-4 and PD-1/PD-L1 blockade, with the exception of
subjects with melanoma.

2. Participants may not have been treated intratumorally with polyICLC.

3. Subjects with history or evidence upon physical examination of central nervous system
(CNS) disease, including primary brain tumor, seizures not controlled with standard
medical therapy, any brain metastases, or, within 6 months of the first date of
treatment on this study, history of cerebrovascular accident (CVA, stroke), transient
ischemic attack (TIA) or subarachnoid hemorrhage.

4. Active, suspected or prior documented autoimmune disease, clinically significant
cardiovascular disease or clinically uncontrolled hypertension.

5. History of pneumonitis or interstitial lung disease or any unresolved immune-related
adverse events following prior biological therapy.

6. Other malignancy within 2 years prior to entry into the study, except for those
treated with surgical therapy only (e.g., localized low-grade cervical or prostate
cancers).

7. Subjects with clinical symptoms or signs of gastrointestinal obstruction and/or who
require drainage gastrostomy tube and/or parenteral hydration or nutrition.

8. Known immunodeficiency or HIV, Hepatitis B, or Hepatitis C positivity. Antibody to
Hepatitis B or C without evidence of active infection may be allowed.

9. History of severe allergic reactions to any unknown allergens or any components of the
study drugs.

10. Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding
disorders).

11. History of allogeneic organ transplant.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Craig L Slingluff, Jr., MD

Role: Study Chair

Affiliation: University of Virginia

Overall Contact

Name: Kristen Aufiero Ramirez

Phone: 212-450-1515

Email: clintrialinformation@licr.org

Locations

Facility Status Contact
Research Facility
Atlanta, Georgia 30322
United States
Recruiting
Research Facility
Buffalo, New York 14263
United States
Recruiting
Research Facility
New York, New York 10029
United States
Recruiting
Research Facility
Cleveland, Ohio 44195
United States
Recruiting Shelley Robinson

robinss@ccf.org
Research Facility
Charlottesville, Virginia 22908
United States
Recruiting Emily H. Allred, PhD, CCRC

eh4m@virginia.edu