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Summary

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

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 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.

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

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 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.

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

Eligibility

You can join if…

Open to people ages 18 years and up

Phase 2 Melanoma patients

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Life expectancy of at least 6 months.
  • Provide tissue for PD-L1 biomarker analysis from a newly obtained biopsy obtained within 28 days of enrollment. Archival tissue within 3 months of screening is acceptable.
  • 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 12 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 12 weeks of study enrollment.

You CAN'T join if...

(Phase 2 Melanoma and HNSCC patients)

  • Received chemotherapy, systemic radiotherapy, or biological cancer therapy (except anti-PD-1/L1 therapy) within 3 weeks prior to study enrollment.
  • 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 Cohort 1 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 T-VEC or other agents given by intratumoral injection and an anti-PD-1/L1 inhibitor.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohort 3 only)

  • Prior therapy with an investigational agent targeting immunoregulatory receptors or mechanisms (exception is prior ipilimumab, which is allowed)
  • Prior therapy with an anti PD 1/L1 agent
  • Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohort 4 only)

  • Any prior combination therapy involving agents given by intratumoral injection and an anti-PD-1/L1 inhibitor.
  • Require treatment on anticoagulation therapy

Locations

  • UCSF accepting new patients
    San Francisco, California, 94158, United States
  • Stanford Hospitals and Clinics accepting new patients
    Palo Alto, California, 94305, 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
Alain Algazi
Study Type
Interventional
Last Updated
December 5, 2017
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