Last updated on March 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Melanoma | head and neck cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria (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.

Exclusion Criteria: (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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.