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Trial record 1 of 1 for:    NCT02521870
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A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Dynavax Technologies Corporation
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT02521870
First received: July 30, 2015
Last updated: April 7, 2017
Last verified: April 2017
  Purpose

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 4 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.


Condition Intervention Phase
Metastatic Melanoma
Head Neck Cancer
Drug: SD-101
Biological: Pembrolizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • Phase 1b - Incidence of dose-limiting toxicities (DLTs). [ Time Frame: DLTs evaluated through 7 days after last dose (Day 29). ]
  • Phase 2 To assess the tumor response both locally and systemically of injected lesions, non-injected lesions, and all lesions. [ Time Frame: Evaluated through Day 743 ]

Secondary Outcome Measures:
  • Phase 2 - Incidence of injection-site reactions, adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Evaluated through Day 743 ]
  • Phase 2 - Time to objective response (TOR) per RECIST 1.1 [ Time Frame: Evaluated through Day 743 ]
  • Phase 2 - Duration of response per RECIST 1.1 [ Time Frame: Evaluated through Day 743 ]
  • Phase 2 - Duration of radiographic progression-free survival (PFS) per RECIST 1.1 [ Time Frame: Evaluated through Day 743 ]

Estimated Enrollment: 156
Study Start Date: September 2015
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation Phase 1b
Determine the MTD of escalating doses of SD-101 administered in combination with pembrolizumab.
Drug: SD-101
SD-101 administered intratumorally at escalating doses (up to 11 doses)
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200 mg Q3W for two years (up to 35 doses)
Experimental: Dose Expansion Phase 2 (1)
Determine the safety and efficacy of SD-101 and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma.
Drug: SD-101
SD-101 administered intratumorally (up to 14 doses)
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses)
Experimental: Dose Expansion Phase 2 (2)
Determine the safety and efficacy of SD-101 and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent or metastatic melanoma.
Drug: SD-101
SD-101 administered intratumorally (up to 14 doses)
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses)
Experimental: Dose Expansion Phase 2 (3)
Determine the safety and efficacy of SD-101 and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma.
Drug: SD-101
SD-101 administered intratumorally (up to 14 doses)
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses)
Experimental: Dose Expansion Phase 2 (4)
Determine the safety and efficacy of SD-101 and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent head and neck squamous cell carcinoma.
Drug: SD-101
SD-101 administered intratumorally (up to 14 doses)
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses)

Detailed Description:

This study will be conducted in two parts.

Phase 1b is dose escalation in which patients are tested with SD-101 at various doses in combination with 200 mg pembrolizumab in patients with metastatic melanoma.

Phase 2 will consist of 4 expansion cohorts to evaluate the efficacy and safety of SD-101 given in combination with 200 mg pembrolizumab in specific melanoma populations and recurrent or metastatic HNSCC.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Phase 2 Melanoma patients

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Provide tissue for PD-L1 biomarker analysis from a newly obtained biopsy obtained within 28 days of enrollment.
  • Must have adequate organ function as indicated by laboratory results.
  • Histologically or cytologically confirmed unresectable in-transit (stage IIIc) or metastatic (stage IV) melanoma.
  • At least 2 sites of measurable disease of which 1 must be palpable or visualized by ultrasound and easily accessible to multiple intratumoral injections. The injected lesions must qualify as a measurable target lesion per RECIST 1.1.
  • Metastatic melanoma patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy must have documented PD per RECIST 1.1 while receiving a prior anti-PD-1/L1 therapy and must have received a prior anti-PD-1/L1 agent within 6 weeks of study enrollment.

Inclusion Criteria: Phase 2 HNSCC patients

  • Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not be treated with curative intent.
  • Have at least 1 measurable site of disease (target lesion per RECIST 1.1, which must be accessible and amenable to multiple intratumoral injections. If superficial, the lesion must measure at least 10 mm in diameter, measured by calipers, and be documented photographically.
  • Recurrent or metastatic HNSCC patients with PD while receiving anti-PD-1/L1 therapy must have documented PD per RECIST 1.1 while receiving anti-PD-1/L1 therapy and must have received anti-PD-1/L1 agent within 6 weeks of study enrollment.

Exclusion Criteria: (Phase 2 Melanoma and HNSCC patients)

  • Is expected to require any other form of anti-cancer therapy while in the trial.
  • Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
  • History of or current uveal or ocular melanoma.
  • Active infection including cytomegalovirus.
  • Active autoimmune disease requiring systemic treatment in the past 2 years or a disease that requires immunosuppressive medication including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.
  • Known active central nervous system metastases or carcinomatous meningitis.
  • Use of any investigational agent within the last 28 days prior to study enrollment.
  • Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
  • Any known additional malignancy that is progressing or requires active treatment, except for melanoma and HNSCC.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02521870

Contacts
Contact: Abraham Leung, MD 510-665-0451
Contact: Robert Janssen, MD 510-665-0457

  Show 55 Study Locations
Sponsors and Collaborators
Dynavax Technologies Corporation
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Antoni Ribas, MD University of California, Los Angeles
  More Information

Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT02521870     History of Changes
Other Study ID Numbers: DV3-MEL-01
Keynote 184 ( Other Identifier: Merck )
Study First Received: July 30, 2015
Last Updated: April 7, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data will be shared under guidance of the New Rule - FDAAA 801 eff. Jan 2017. 3/2017 - additional changes forthcoming.

Keywords provided by Dynavax Technologies Corporation:
Skin Cancer
Skin Tumors
Head and Neck Squamous Cell Carcinoma
Cancer Immunotherapy

Additional relevant MeSH terms:
Carcinoma
Melanoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Squamous Cell
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 25, 2017