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Brief Title: A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab Plus 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

INTRODUCTION

  • Org Study ID: LUD2014-011
  • Secondary ID: N/A
  • NTC ID: NCT02643303
  • Sponsor: 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.


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

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: 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


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 active 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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Craig L Slingluff, Jr., MD

Role: Study Chair

Affiliation: University of Virginia

Overall Contact

Name: Craig L Slingluff, Jr., MD

Phone: 212-450-1515

Email: clintrialinformation@licr.org

LOCATION

Facility Status Contact
Facility: Research Facility
Atlanta, Georgia 30322
United States 		Status: Recruiting Contact: N/A
Facility: Research Facility
Lebanon, New Hampshire 03756
United States 		Status: Recruiting Contact: N/A
Facility: Research Facility
Buffalo, New York 14263
United States 		Status: Recruiting Contact: N/A
Facility: Research Facility
New York, New York 10029
United States 		Status: Recruiting Contact: N/A
Facility: Research Facility
Cleveland, Ohio 44195
United States 		Status: Recruiting Contact:
Shelley Robinson

robinss@ccf.org
Facility: Research Facility
Charlottesville, Virginia 22908
United States 		Status: Recruiting Contact:
Adela Mahmutovic

am6bd@hscmail.mcc.virginia.edu

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