A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab Plus PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers
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ClinicalTrials.gov Identifier: NCT02643303 |
Recruitment Status :
Completed
First Posted : December 31, 2015
Last Update Posted : March 3, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 | Drug: Durvalumab Drug: Tremelimumab Drug: Poly ICLC | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 28, 2016 |
Actual Primary Completion Date : | February 23, 2022 |
Actual Study Completion Date : | February 23, 2022 |

Arm | Intervention/treatment |
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Experimental: Phase 1, Cohort 1A
IV Durvalumab + IT/IM polyICLC
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Drug: Durvalumab
Other Name: MEDI4736 Drug: Poly ICLC Other Name: Hiltonol |
Experimental: Phase 1, Cohort 1B
IV Durvalumab + IV Tremelimumab + IT/IM polyICLC
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Drug: Durvalumab
Other Name: MEDI4736 Drug: Tremelimumab Drug: Poly ICLC Other Name: Hiltonol |
Experimental: Phase 1, Cohort 1C
IV Durvalumab + IT Tremelimumab + IT/IM polyICLC
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Drug: Durvalumab
Other Name: MEDI4736 Drug: Tremelimumab Drug: Poly ICLC Other Name: Hiltonol |
Experimental: Phase 2 Cohort
Once the recommended combination doses of the triplet dosing regimen has been determined in Cohort 1C, subsequent subjects will be enrolled into Cohort 2 to receive the recommended combination doses of both checkpoint antibodies in combination with polyICLC.
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Drug: Durvalumab
Other Name: MEDI4736 Drug: Tremelimumab Drug: Poly ICLC Other Name: Hiltonol |
- Progression-Free Survival (PFS) at 24 weeks [ Time Frame: up to 24 weeks ]Analyzed by irRECIST
- Safety and tolerability [ Time Frame: up to 15 months ]Adverse events according to CTCAE V4.03
- Clinical Efficacy by objective response rate (ORR) [ Time Frame: up to 15 months ]assessed by irRECIST
- Clinical Efficacy by progression-free survival (PFS) [ Time Frame: up to 15 months ]assessed by irRECIST
- Clinical Efficacy by overall survival (OS) [ Time Frame: up to 15 months ]assessed by irRECIST

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
- 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).
- Any number of prior systemic therapies.
- ECOG performance status 0-1.
- Laboratory parameters for vital functions should be in the normal range or not clinically significant.
Exclusion Criteria:
- Prior treatment with combination CTLA-4 and PD-1/PD-L1 blockade, with the exception of subjects with melanoma.
- Participants may not have been treated intratumorally with polyICLC.
- 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.
- Active, suspected or prior documented autoimmune disease, clinically significant cardiovascular disease or clinically uncontrolled hypertension.
- History of pneumonitis or interstitial lung disease or any unresolved immune-related adverse events following prior biological therapy.
- 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).
- Subjects with clinical symptoms or signs of gastrointestinal obstruction and/or who require drainage gastrostomy tube and/or parenteral hydration or nutrition.
- Known immunodeficiency or HIV, Hepatitis B, or Hepatitis C positivity. Antibody to Hepatitis B or C without evidence of active infection may be allowed.
- History of severe allergic reactions to any unknown allergens or any components of the study drugs.
- Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
- History of allogeneic organ transplant.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643303
United States, Georgia | |
Research Facility | |
Atlanta, Georgia, United States, 30322 | |
United States, New Hampshire | |
Research Facility | |
Lebanon, New Hampshire, United States, 03756 | |
United States, New York | |
Research Facility | |
Buffalo, New York, United States, 14263 | |
Research Facility | |
New York, New York, United States, 10029 | |
United States, Ohio | |
Research Facility | |
Cleveland, Ohio, United States, 44195 | |
Research Facility | |
Toledo, Ohio, United States, 43614 | |
United States, Virginia | |
Research Facility | |
Charlottesville, Virginia, United States, 22908 |
Study Chair: | Craig L Slingluff, Jr., MD | University of Virginia | |
Study Chair: | Nina Bhardwaj, MD, PhD | Tisch Cancer Institute Ichan School of Medicine at Mount Sinai |
Responsible Party: | Ludwig Institute for Cancer Research |
ClinicalTrials.gov Identifier: | NCT02643303 |
Other Study ID Numbers: |
LUD2014-011 |
First Posted: | December 31, 2015 Key Record Dates |
Last Update Posted: | March 3, 2022 |
Last Verified: | March 2022 |
Durvalumab MEDI4736 Tremelimumab PolyICLC Hiltonol Locally Recurrent Breast Cancer |
Metastatic Melanoma In Situ CTLA-4 Antibody PD-L1 Antibody TLR3 Agonist CTCL |
Carcinoma, Merkel Cell Carcinoma Melanoma Squamous Cell Carcinoma of Head and Neck Lymphoma, T-Cell, Cutaneous Kidney Neoplasms Testicular Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Genital Neoplasms, Male Urogenital Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Carcinoma, Squamous Cell Urologic Neoplasms Urologic Diseases Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoma Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Head and Neck Neoplasms Kidney Diseases |