Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Ezra Cohen

Description

Summary

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 7 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.

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 (SYNERGY-001)

Details

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 7 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.

Keywords

Metastatic Melanoma Head Neck Cancer Skin Cancer Skin Tumors Head and Neck Squamous Cell Carcinoma Cancer Immunotherapy Carcinoma Melanoma Carcinoma, Squamous Cell Head and Neck Neoplasms Pembrolizumab SD-101(1) SD-101(2)

Eligibility

You can join if…

Open to people ages 18 years and up

(Phase 1 and 2 Melanoma and HNSCC patients)

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Life expectancy of at least 6 months.
  • Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

  • Histologically or cytologically confirmed unresectable or metastatic (stage IV)melanoma.
  • Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of which 1 must be palpable or visualized by ultrasound and easily accessible to multiple intratumoral injections.
  • For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

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 target lesion per RECIST 1.1, which must be accessible and amenable to multiple intratumoral injections.
  • Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

You CAN'T join if...

(Phase 1 and 2 Melanoma and HNSCC patients)

  • Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1 therapy) within 3 weeks prior to study enrollment.
  • Received prior radiotherapy within 2 weeks of start of study therapy.
  • Received small molecule inhibitor targeted therapy, such as tyrosine kinase inhibitors, within 2 weeks prior to study enrollment.
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy (including immune modulators or systemic corticosteroids) within 7 days prior to study enrollment
  • 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. Replacement therapy 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.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

  • Any prior combination therapy targeting immunoregulatory receptors or mechanisms and an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors
  • Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

  • Prior therapy with an anti PD 1/L1 agent
  • Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

  • Any prior combination therapy involving agents given by intratumoral injection that target the innate immune pathway or system.
  • Require treatment on anticoagulation therapy

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dynavax Technologies Corporation
ID
NCT02521870
Phase
Phase 1/2
Lead Scientist
Ezra Cohen
Study Type
Interventional
Last Updated