Head and Neck Squamous Cell CarcinomaPhase 1/2NCT02643303

A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers

A Phase 1/2 study testing Durvalumab, Tremelimumab and Poly-ICLC in people with Head and Neck Squamous Cell Carcinoma and Breast Cancer, run by Ludwig Institute for Cancer Research at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 poly-ICLC, a TLR3 agonist, in subjects with advanced, measurable, biopsy-accessible cancers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Squamous Cell Carcinoma, Breast Cancer, Sarcoma
What is being tested?: Durvalumab, Tremelimumab and Poly-ICLC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 7 sitesUnited States
Study dates: 28 Dec 2016to 23 Feb 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 human papillomavirus (HPV)-associated HNSCC after failure of prior therapy
Locally recurrent or metastatic breast cancer
Sarcoma
Merkel Cell Carcinoma (MCC)
Cutaneous T cell Lymphoma (CTCL)

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Melanoma after failure of available therapies
Genitourinary (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 does not need to be measurable).
Any number of prior systemic therapies.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Laboratory parameters for vital functions should be in the normal range or not clinically significant.

Who cannot join

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 poly-ICLC.
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).

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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.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Research Facility
Atlanta, Georgia, 30322
Research Facility
Buffalo, New York, 14263
Research Facility
Charlottesville, Virginia, 22908
Research Facility
Cleveland, Ohio, 44195
Research Facility
Lebanon, New Hampshire, 03756
Research Facility
New York, New York, 10029
Research Facility
Toledo, Ohio, 43614

Other trials in United States

About this study

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

Read the detailed description

This is an open-label, multicenter, Phase 1/2 study of the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody, tremelimumab, and the programmed cell death ligand-1 (PD-L1) antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment (TME) modulator poly-ICLC, a toll-like receptor 3 (TLR3) agonist, in subjects with advanced, measurable, biopsy-accessible cancers. Subjects will receive intratumoral and intramuscular (IM) administration of poly-ICLC and intravenous (IV) administration of durvalumab, together with either IV or intratumoral administration of tremelimumab. The study will be conducted in 2 phases.

Phase 1: There will be enrollment to 3 subject cohorts in Phase 1, with staggered initiation of enrollment.

Cohort 1A: IV Durvalumab + Intratumoral/IM Poly-ICLC. After safety is demonstrated in the first 3-6 subjects in Cohort 1A, Cohorts 1B and 1C will open to enrollment.
Cohort 1B: IV Durvalumab + IV Tremelimumab + Intratumoral/IM Poly-ICLC.
Cohort 1C: IV Durvalumab + Intratumoral Tremelimumab + Intratumoral/IM Poly-ICLC.

Phase 2: Upon determination of the recommended combination dose in Cohort 1C, up to 66 evaluable subjects will be treated in Phase 2. Up to 6 subjects will be initially enrolled by tumor type (head and neck squamous cell carcinoma, locally recurrent or metastatic breast cancer, sarcoma, Merkel cell carcinoma, cutaneous T-cell lymphoma, melanoma after failure of available therapies, genitourinary cancers and solid tumors with accessible metastases). Subjects enrolled in Cohort 1C will be included in Phase 2 in the applicable tumor type. Data from all subjects in each Phase 2 tumor type will be reviewed for safety/efficacy to select up to 3 tumor types that demonstrate an efficacy signal, defined as at least 1 of 6 subjects within a tumor type who achieve a partial response (PR) or complete response (CR) by immune-related RECIST (irRECIST) or RECIST 1.1, or stable disease (SD) for at least 6 months. Up to 6 additional subjects in each of the selected tumor types may be enrolled in the expansion.

Conditions: Head and Neck Squamous Cell Carcinoma, Breast Cancer, Sarcoma, Merkel Cell Carcinoma, Cutaneous T-Cell Lymphoma, Melanoma
Being tested: Durvalumab, Tremelimumab, Poly-ICLC
Keywords: Durvalumab, MEDI4736, Tremelimumab, Poly-ICLC, Hiltonol®, Breast Cancer, Melanoma, In Situ, CTLA-4 Antibody, PD-L1 Antibody, TLR3 Agonist, CTCL, Imfinzi®
Medical subject headings: Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Sarcoma, Carcinoma, Merkel Cell, Lymphoma, T-Cell, Cutaneous, Melanoma, Kidney Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DurvalumabDrug
Also called MEDI4736, Imfinzi®
TremelimumabDrug
Poly-ICLCDrug
Also called Hiltonol®

Study groups in NCT02643303
Study group	Role	What they receive
Phase 1, Cohort 1A	Experimental	Subjects received durvalumab (1500 mg IV every 4 weeks [Q4W] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Receives: Drug: Durvalumab; Drug: Poly-ICLC
Phase 1, Cohort 1B	Experimental	Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Receives: Drug: Durvalumab; Drug: Tremelimumab; Drug: Poly-ICLC
Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma	Experimental	Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Receives: Drug: Durvalumab; Drug: Tremelimumab; Drug: Poly-ICLC
Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer	Experimental	Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Receives: Drug: Durvalumab; Drug: Tremelimumab; Drug: Poly-ICLC
Cohort 1C + Phase 2; Sarcoma	Experimental	Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Receives: Drug: Durvalumab; Drug: Tremelimumab; Drug: Poly-ICLC
Cohort 1C + Phase 2; Merkel Cell Carcinoma	Experimental	Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Receives: Drug: Durvalumab; Drug: Tremelimumab; Drug: Poly-ICLC
Cohort 1C + Phase 2; Cutaneous T-cell Lymphoma	Experimental	Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Receives: Drug: Durvalumab; Drug: Tremelimumab; Drug: Poly-ICLC
Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies	Experimental	Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Receives: Drug: Durvalumab; Drug: Tremelimumab; Drug: Poly-ICLC
Cohort 1C + Phase 2; Genitourinary Cancers with Accessible Metastases	Experimental	Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Receives: Drug: Durvalumab; Drug: Tremelimumab; Drug: Poly-ICLC
Cohort 1C + Phase 2; Solid Tumors with Accessible Masses	Experimental	Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Receives: Drug: Durvalumab; Drug: Tremelimumab; Drug: Poly-ICLC

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after administration of the first dose of study treatment.
Measured: up to 15 months
Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measured Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria.
Measured: up to 15 months

Secondary outcomes (6)

Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment.
PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression did not occur. Per irRECIST, Progressive Disease (irPD) was defined as a ≥ 20% increase from nadir in the Total Measured Tumor Burden (TMTB).
Measured: up to 15 months
Overall Disease Control Rate as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measurable Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria.
Overall Disease Control Rate was defined as the percentage of subjects who had irSD for at least 6 months, or irPR or irCR over a period of at least 4 weeks. Subjects who dropped out prior to meeting the responder criteria were considered non-responders.
Measured: Up to 24 weeks
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per RECIST 1.1, target lesions are categorized as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions or presence of new lesions; Stable Disease (SD): small changes that did not meet above criteria.
Measured: up to 13 months
Median PFS by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Estimated Using the Kaplan-Meier Method
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment.
PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression according to RECIST 1.1 or to the date of death, if disease progression did not occur. Per RECIST 1.1, Progressive disease (PD) was defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions.
Measured: Up to 15 months
Overall Disease Control Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per RECIST 1.1, target lesions are categorized as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions or presence of new lesions; Stable Disease (SD): small changes that did not meet above criteria.
Overall Disease Control Rate was defined as the percentage of subjects who had SD for at least 6 months, or PR or CR over a period of at least 4 weeks. Subjects who dropped out prior to meeting the responder criteria were considered non-responders.
Measured: up to 24 weeks
Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method
After completion of treatment, all subjects were followed for survival every 3 months for 2 years after completion of treatment; then every 6 months until 5 years from study entry; then yearly until 10 years from study entry. OS was measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up were censored on the date when they were last known to be alive. Per protocol amendment 6.0, all post study follow-up for the collection of survival data was discontinued as of February 28, 2022. The last collection of survival data was on February 23, 2022.
Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Dec 201623 Feb 2022

First posted31 Dec 2015 (estimated)
Study start28 Dec 2016
Primary completion23 Feb 2022
Study completion23 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: In Phase 1, Cohort 1A was opened first and after the safety of durvalumab and poly-ICLC was demonstrated, Cohorts 1B and 1C were open in parallel. In Phase 2, all tumor types were opened in parallel, and subjects included in Cohort 1C were included and reported in their respective tumor type in Phase 2.
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02643303
Sponsor's protocol ID: LUD2014-011
Status last verified: Nov 2022
First submitted: 18 Dec 2015
Last updated: 2 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774
Bohnsack O, Hoos A, Ludajic K. Adaptation of the immune related response criteria: irRECIST. Ann Oncol. 2014 Sep;25(suppl 4):iv361-iv72 [Abstract 4958]. doi: 10.1093/annonc/mdu342.23.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab (MEDI4736) Plus the Toll-like Receptor Agonist Poly-ICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers
ClinicalTrials.gov ID: NCT02643303
Acronym / sponsor ID: LUD2014-011
Conditions: Head and Neck Squamous Cell Carcinoma, Breast Cancer, Sarcoma, Merkel Cell Carcinoma, Cutaneous T-Cell Lymphoma, Melanoma
Keywords: Durvalumab, MEDI4736, Tremelimumab, Poly-ICLC, Hiltonol®, Breast Cancer, Melanoma, In Situ
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Ludwig Institute for Cancer ResearchUniversity, hospital or other
Collaborators: MedImmune LLC, Cancer Research Institute, New York City
Study start: 28 Dec 2016 (actual)
Primary completion: 23 Feb 2022 (actual)
Study completion: 23 Feb 2022 (actual)
First posted: 31 Dec 2015 (estimated)
Results: Posted 2 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Phase 1: There will be enrollment to 3 subject cohorts in Phase 1, with staggered initiation of enrollment.

Cohort 1A: IV Durvalumab + Intratumoral/IM Poly-ICLC. After safety is demonstrated in the first 3-6 subjects in Cohort 1A, Cohorts 1B and 1C will open to enrollment.
Cohort 1B: IV Durvalumab + IV Tremelimumab + Intratumoral/IM Poly-ICLC.
Cohort 1C: IV Durvalumab + Intratumoral Tremelimumab + Intratumoral/IM Poly-ICLC.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 10
Model description: In Phase 1, Cohort 1A was opened first and after the safety of durvalumab and poly-ICLC was demonstrated, Cohorts 1B and 1C were open in parallel. In Phase 2, all tumor types were opened in parallel, and subjects included in Cohort 1C were included and reported in their respective tumor type in Phase 2.

Arm	Type	Receives
Phase 1, Cohort 1A	Experimental	Drug: Durvalumab, Drug: Poly-ICLCSubjects received durvalumab (1500 mg IV every 4 weeks [Q4W] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.
Phase 1, Cohort 1B	Experimental	Drug: Durvalumab, Drug: Tremelimumab, Drug: Poly-ICLCSubjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.
Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma	Experimental	Drug: Durvalumab, Drug: Tremelimumab, Drug: Poly-ICLCSubjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.
Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer	Experimental	Drug: Durvalumab, Drug: Tremelimumab, Drug: Poly-ICLCSubjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.
Cohort 1C + Phase 2; Sarcoma	Experimental	Drug: Durvalumab, Drug: Tremelimumab, Drug: Poly-ICLCSubjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.
Cohort 1C + Phase 2; Merkel Cell Carcinoma	Experimental	Drug: Durvalumab, Drug: Tremelimumab, Drug: Poly-ICLCSubjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.
Cohort 1C + Phase 2; Cutaneous T-cell Lymphoma	Experimental	Drug: Durvalumab, Drug: Tremelimumab, Drug: Poly-ICLCSubjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.
Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies	Experimental	Drug: Durvalumab, Drug: Tremelimumab, Drug: Poly-ICLCSubjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.
Cohort 1C + Phase 2; Genitourinary Cancers with Accessible Metastases	Experimental	Drug: Durvalumab, Drug: Tremelimumab, Drug: Poly-ICLCSubjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.
Cohort 1C + Phase 2; Solid Tumors with Accessible Masses	Experimental	Drug: Durvalumab, Drug: Tremelimumab, Drug: Poly-ICLCSubjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Subjects must have histologic confirmation of advanced, biopsy-accessible, measurable cancers of the following histologies:
Subjects with measurable disease, must have at least 2 lesions (1 measurable lesion and 1 biopsy/injectable lesion, which does not need to be measurable).
Any number of prior systemic therapies.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Laboratory parameters for vital functions should be in the normal range or not clinically significant.

Key exclusion criteria (11 listed)

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 poly-ICLC.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DurvalumabAlso: MEDI4736, Imfinzi®	Drug	Cohort 1C + Phase 2; Cutaneous T-cell Lymphoma, Cohort 1C + Phase 2; Genitourinary Cancers with Accessible Metastases, Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma, Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer, Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies, Cohort 1C + Phase 2; Merkel Cell Carcinoma, Cohort 1C + Phase 2; Sarcoma, Cohort 1C + Phase 2; Solid Tumors with Accessible Masses, Phase 1, Cohort 1A, Phase 1, Cohort 1B
Tremelimumab	Drug	Cohort 1C + Phase 2; Cutaneous T-cell Lymphoma, Cohort 1C + Phase 2; Genitourinary Cancers with Accessible Metastases, Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma, Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer, Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies, Cohort 1C + Phase 2; Merkel Cell Carcinoma, Cohort 1C + Phase 2; Sarcoma, Cohort 1C + Phase 2; Solid Tumors with Accessible Masses, Phase 1, Cohort 1B
Poly-ICLCAlso: Hiltonol®	Drug	Cohort 1C + Phase 2; Cutaneous T-cell Lymphoma, Cohort 1C + Phase 2; Genitourinary Cancers with Accessible Metastases, Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma, Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer, Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies, Cohort 1C + Phase 2; Merkel Cell Carcinoma, Cohort 1C + Phase 2; Sarcoma, Cohort 1C + Phase 2; Solid Tumors with Accessible Masses, Phase 1, Cohort 1A, Phase 1, Cohort 1B

Primary outcome

Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: up to 15 months
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after administration of the first dose of study treatment.
Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Time frame: up to 15 months
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measured Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria.

6 secondary outcomes

Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method
Time frame: up to 15 months
Overall Disease Control Rate as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Time frame: Up to 24 weeks
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: up to 13 months
Median PFS by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Estimated Using the Kaplan-Meier Method
Time frame: Up to 15 months
Overall Disease Control Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: up to 24 weeks
Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method
Time frame: up to 5 years

Results and safety

Results posted to the registry on 2 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1, Cohort 1A	4	0
Phase 1, Cohort 1B	5	0
Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma	1	0
Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer	15	2
Cohort 1C + Phase 2; Sarcoma	7	0
Cohort 1C + Phase 2; Merkel Cell Carcinoma	4	0
Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies	10	1
Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases	3	0
Cohort 1C + Phase 2; Solid Tumors With Accessible Masses	7	0

Primary outcome: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

Time frame: up to 15 months. Count of participants. Unit: Participants

Measure	Phase 1, Cohort 1A n = 4	Phase 1, Cohort 1B n = 5	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n = 1	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n = 15	Cohort 1C + Phase 2; Sarcoma n = 7	Cohort 1C + Phase 2; Merkel Cell Carcinoma n = 4	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n = 10	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n = 3	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n = 7
Number of Subjects with TEAEs	4	5	1	15	7	4	10	3	7
Number of Subjects with Treatment-Related TEAEs (TRAEs)	4	4	1	13	6	3	10	1	7
Number of Subjects with Serious TRAEs	0	1	0	0	0	0	0	0	0
Number of Subjects with Dose-Limiting Toxicities (DLTs)	0	1	0	0	0	0	0	0	0
Number of Subjects who Died on Study	0	2	0	3	1	1	1	2	0

Population analysed: All subjects who received at least one dose of study treatment.

Primary outcome: Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)

Time frame: up to 15 months. Count of participants. Unit: Participants

Measure	Phase 1, Cohort 1A n = 4	Phase 1, Cohort 1B n = 4	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n = 1	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n = 14	Cohort 1C + Phase 2; Sarcoma n = 7	Cohort 1C + Phase 2; Merkel Cell Carcinoma n = 4	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n = 9	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n = 2	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n = 6
irCR	1	0	0	0	0	0	0	0	0
irPR	0	0	0	3	0	0	0	0	0
irSD	2	0	0	2	1	0	3	0	3
irPD	1	4	1	9	6	4	6	2	3

Population analysed: All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1, Cohort 1A	0 of 4 (0%)	4 of 4 (100%)	3 of 4
Phase 1, Cohort 1B	3 of 5 (60%)	5 of 5 (100%)	5 of 5
Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer	4 of 15 (26.7%)	15 of 15 (100%)	9 of 15
Cohort 1C + Phase 2; Sarcoma	3 of 7 (42.9%)	7 of 7 (100%)	6 of 7
Cohort 1C + Phase 2; Merkel Cell Carcinoma	2 of 4 (50%)	4 of 4 (100%)	4 of 4
Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies	3 of 10 (30%)	10 of 10 (100%)	6 of 10
Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
Cohort 1C + Phase 2; Solid Tumors With Accessible Masses	2 of 7 (28.6%)	7 of 7 (100%)	6 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
BackgroundBohnsack O, Hoos A, Ludajic K. Adaptation of the immune related response criteria: irRECIST. Ann Oncol. 2014 Sep;25(suppl 4):iv361-iv72 [Abstract 4958]. doi: 10.1093/annonc/mdu342.23.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Craig L Slingluff, Jr., MD study chair

University of Virginia

Nina Bhardwaj, MD, PhD study chair

Tisch Cancer Institute Icahn School of Medicine at Mount Sinai

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Treatment-emergent Adverse Events (TEAEs) (time frame: up to 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02643303, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.