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History of Changes for Study: NCT02521870
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
Latest version (submitted June 10, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 10, 2015 Nothing (earliest Version on record)
2 September 9, 2015
Recruitment Status
, Study Status and Contacts/Locations
3 April 13, 2016 Arms and Interventions, Study Status, Outcome Measures, Study Design, Study Description, Contacts/Locations, Eligibility, Oversight and Study Identification
4 July 20, 2016 Contacts/Locations and Study Status
5 August 23, 2016 Study Status
6 January 30, 2017 Contacts/Locations, Arms and Interventions, Outcome Measures, Study Status, Conditions, Study Description, Study Identification, IPDSharing, Eligibility and Study Design
7 March 2, 2017 Study Status and IPDSharing
8 April 7, 2017 Contacts/Locations and Study Status
9 November 14, 2017 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Status, Eligibility and Study Design
10 December 5, 2017 Contacts/Locations and Study Status
11 February 27, 2018 Contacts/Locations and Study Status
12 April 3, 2018 Study Status and Contacts/Locations
13 May 17, 2018 Contacts/Locations and Study Status
14 June 1, 2018 Contacts/Locations, Study Status, Study Description, Study Identification, Eligibility and Study Design
15 March 18, 2019 Contacts/Locations, Outcome Measures, Study Status, Arms and Interventions, Study Description, Eligibility and Study Design
16 June 10, 2019
Recruitment Status
, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Changes (Merged) for Study: NCT02521870
June 1, 2018 (v14) -- March 18, 2019 (v15)

Changes in: Contacts/Locations, Outcome Measures, Study Status, Arms and Interventions, Study Description, Eligibility and Study Design

Study Identification
Unique Protocol ID: DV3-MEL-01
Brief Title: 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
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)
Secondary IDs: Keynote 184 [Merck]
SYNERGY-001 [Dynavax]
Study Status
Record Verification: June 2018 March 2019
Overall Status: Recruiting
Study Start: September 2015
Primary Completion: February 2020 [Anticipated]
Study Completion: February 2020 [Anticipated]
First Submitted: July 30, 2015
First Submitted that
Met QC Criteria:
August 10, 2015
First Posted: August 13, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 1, 2018 March 18, 2019
Last Update Posted: June 5, 2018 [Estimate] March 20, 2019 [Actual]
Sponsor/Collaborators
Sponsor: Dynavax Technologies Corporation
Responsible Party: Sponsor
Collaborators: Merck Sharp & Dohme Corp.
Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Study Description
Brief 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 ) .

This study will be conducted in 2 phases. Phase 1 evaluates SD-101 given in combination with pembrolizumab in melanoma populations (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease) in up to 4 Dose Escalation cohorts to identify an RP2D to be evaluated in up to 4 Dose Expansion cohorts in Phase 2. Phase 2 also includes up to 4 Dose Expansion cohorts of patients with HNSCC (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease).

The following schema presents the study design for melanoma Phase 1 and Phase 2 and for HNSCC Phase 2.

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.

Detailed Description:

This study will be conducted in two parts.

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. Phase 1 evaluates SD-101 given in combination with pembrolizumab in melanoma populations (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease) in up to 4 Dose Escalation cohorts to identify an RP2D to be evaluated in up to 4 Dose Expansion cohorts in Phase 2.

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 also includes up to 4 Dose Expansion cohorts of patients with HNSCC (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease)

Conditions
Conditions: Metastatic Melanoma
Head Neck Cancer
Keywords: Skin Cancer
Skin Tumors
Head and Neck Squamous Cell Carcinoma
Cancer Immunotherapy
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 5 9
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 234 284 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Experimental: Dose Escalation Phase 1b
Determine the MTD of escalating doses of SD-101(1) administered in combination with pembrolizumab.
Drug: SD-101(1)
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(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma.
Drug: SD-101(2)
SD-101 administered intratumorally (up to 22 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(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent or metastatic melanoma.
Drug: SD-101(2)
SD-101 administered intratumorally (up to 22 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(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma.
Drug: SD-101(2)
SD-101 administered intratumorally (up to 22 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(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent head and neck squamous cell carcinoma.
Drug: SD-101(2)
SD-101 administered intratumorally (up to 22 doses)
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses)
Experimental: Dose Expansion Phase 2 (5)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma.
Biological: SD-101(3)
4 weekly doses of SD-101 starting from Day 1 followed by 1 dose Q3W for 16 additional doses (up to 20 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses)
Experimental: Dose Expansion Phase 2 (6)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma.
Biological: SD-101(3)
4 weekly doses of SD-101 starting from Day 1 followed by 1 dose Q3W for 16 additional doses (up to 20 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses)
Experimental: Dose Expansion Phase 2 (7)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent head and neck squamous cell carcinoma.
Biological: SD-101(3)
4 weekly doses of SD-101 starting from Day 1 followed by 1 dose Q3W for 16 additional doses (up to 20 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses)
Experimental: Dose Expansion Phase 2 (8)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent or metastatic melanoma.
Biological: SD-101(3)
4 weekly doses of SD-101 starting from Day 1 followed by 1 dose Q3W for 16 additional doses (up to 20 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses)
Outcome Measures
Primary Outcome Measures:
1. Phase 1b - Incidence of dose-limiting toxicities (DLTs).
DLTs evaluated through 7 days after last dose

[Time Frame: Day 29]
2. Phase 2 Overall response rate (ORR) per RECIST v1.1
Evaluated through Day 743

[Time Frame: Day 743]
3. Phase 2 1b - To assess the tumor response both locally and systemically of injected lesions, non-injected lesions, and all lesions.
Evaluated through Day 743

[Time Frame: Day 743]
4. Phase 1b - To assess changes in the expression of IFN-inducible genes in whole blood.
Evaluated through Day 9

[Time Frame: Day 9]
Secondary Outcome Measures:
5. Phase 2 - Incidence of injection-site reactions, adverse events (AEs) and serious adverse events (SAEs)
Evaluated through Day 743

[Time Frame: Day 743]
6. Phase 2 - Time to objective response (TOR) per RECIST 1.1
Evaluated through Day 743

[Time Frame: Day 743]
7. Phase 2 - Duration of response per RECIST 1.1
Evaluated through Day 743

[Time Frame: Day 743]
8. Phase 2 - Duration of radiographic progression-free survival (PFS) per RECIST 1.1
Evaluated through Day 743

[Time Frame: Day 743]
9. Phase 1b - Objective Response Rate per RECIST v1.1
Evaluated through Day 743

[Time Frame: Day 743]
10. Phase 1b - Disease control rate (DCR) per RECIST v1.1
Evaluated through Day 743

[Time Frame: Day 743]
11. Phase 1b - Time to Response per REVIST v1.1
Evaluated through Day 743

[Time Frame: Day 743]
12. Phase 1b - Changes in tumor-infiltrating lymphocytes, PD-L1 expression, and other gene expression in tumor biopsies
Evaluated through Day 169

[Time Frame: Day 169]
13. Phase 2 To assess the tumor response both locally and systemically of injected lesions, non-injected lesions, and all lesions.
Evaluated through Day 743

[Time Frame: Day 743]
Other Pre-specified Outcome Measures:
14. Phase 2 - Radiographic primary and secondary endpoints evaluated using irRECIST
Evaluated through Day 743

[Time Frame: Day 743]
15. Phase 2 - Changes in correlative biomarkers including tumor-infiltrating lymphocytes and PD-L1 expression at baseline and after SD-101 treatment
Evaluated through Day 743

[Time Frame: Day 743]
16. Phase 2 - Changes in potential tumor neoantigens in patients with recurrent or metastatic HNSCC
Evaluated at Screening

[Time Frame: Screening]
17. Phase 2 - Changes in the expression of IFN-inducible genes in whole blood in patients with metastatic head and neck squamous cell carcinoma
Evaluated through Day 9

[Time Frame: Day 9]
Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:
  • 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

A patient must meet all of the following criteria to be eligible for enrollment (defined as receiving the first trial treatment [ie, pembrolizumab or SD-101]) in the trial:

Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients) ~Phase 1 and Phase 2

  1. Willing and able to provide written informed consent for the trial
  2. Aged 18 years and older
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
  4. Patient must have adequate organ function as indicated by the following laboratory values:

    Hematological • Absolute neutrophil count (ANC) ≥ 1,500 /mcL

    • Platelet count ≥ 100,000 /mcL

    • Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L Renal
    • Serum creatinine ≤ 1.5 × upper limit of normal (ULN) OR
    • Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥ 60 mL/min for subject with creatinine levels > 1.5 × institutional ULN Hepatic
    • Serum total bilirubin:
    • ≤ 1.5 × ULN OR
    • < 3 × ULN for persons with Gilbert's syndrome OR
    • Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 × ULN
    • Aspartate transaminase (AST) and alanine transaminase (ALT) (also known as serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase)
    • ≤ 2.5 × ULN OR
    • ≤ 5 × ULN for patients with liver metastases Coagulation
    • International normalized ratio or prothrombin time (PT) ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy, and as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
    • Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy, and as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  5. Have provided 2 tissue biopsy samples taken of the target lesion (Lesion A) as a single biopsy split into 2 samples or 2 separate biopsies that meet the minimal sample size requirement per the study laboratory manual. One sample is for determining PD-L1 expression level by immunohistochemistry and can be an archival sample of the anticipated target lesion that has been collected within 3 months of screening. The other sample is for RNA expression profiling and must be a fresh biopsy.
  6. Life expectancy of at least 6 months
  7. Female patients of childbearing potential, as defined in Section 5.2.1, must have a negative urine or serum pregnancy test within 72 hours prior to taking the first dose of trial treatment. If the urine test is positive or cannot be confirmed as negative then a serum test is required which must be negative for the patient to enroll. Women of childbearing potential (WOCBP) must be willing to use 2 medically acceptable methods of contraceptive from Day 1 through 120 days after the last dose of trial treatment. The 2 medically acceptable birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide as per local regulations or guidelines. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).

    Male patients of reproductive potential, as described in Section 5.2.1, must agree to use an adequate method of contraception from Day 1 through 120 days after the last dose of trial treatment.

    Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.

    • Inclusion Criteria (Phase 1 only: Melanoma)

    A patient must meet the following to be eligible for Phase 1:

  8. Histologically or cytologically confirmed unresectable or metastatic (stage IV) melanoma
  9. For Phase 1 Escalation Cohorts 1-4, must have at least 1 lesion that qualifies as a target lesion per RECIST v1.1 except for the minimum measurement of 10 mm in diameter for superficial lesions, is easily accessible (palpable or can be visualized by ultrasound), and is amenable to multiple intratumoral injections. If superficial, the target lesion must be documented photographically.

    \.

    ~Inclusion Criteria (Phase 2 only: Melanoma)

    A patient must meet the following to be eligible for Phase 2 (as applicable to the expansion cohorts):

  10. Histologically or cytologically confirmed recurrent or unresectable or metastatic (stage IV) melanoma
  11. Must have at least 2 lesions that qualify as a target lesion per RECIST v1.1, and 1 of the qualifying lesions must be easily accessible (palpable or can be visualized by ultrasound) and amenable to multiple intratumoral injections. The target lesion should be of sufficient size such that the required tumor biopsies do not significantly affect tumor assessment per RECIST v1.1. If superficial, the target lesion must measure at least 10 mm in diameter, be measured by calipers, and be documented photographically. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion. Approval from the Medical Monitor is required to inject a previously radiated lesion.
  12. Expansion Cohort 2: Must have documented PD per RECIST v1.1 on a prior treatment regimen containing an anti-PD-1/L1 drug (see Appendix 6 for definition of PD per RECIST v1.1)
  13. Expansion Cohort 8: Must have all of the following:

    a) Received at least 2 doses of an anti-PD-1/L1 therapy b) PD occurred within 3 months after last dose of anti-PD-1/L1 therapy c) Documented PD per RECIST v.1.1, which has been confirmed by a second assessment at least 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression

    \.

    ~Inclusion Criteria (Phase 2 only: HNSCC)

    A patient must meet the following to be eligible for Phase 2 (as applicable to the expansion cohorts):

  14. Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not be treated with curative intent.
  15. Must have at least 1 lesion that qualifies as a target lesion per RECIST v1.1, and which must be easily accessible (palpable or can be visualized by ultrasound) and amenable to multiple intratumoral injections. The target lesion should be of sufficient size such that the required tumor biopsies do not significantly affect tumor assessment per RECIST v1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion. Approval from the Medical Monitor is required to inject a previously radiated lesion.
  16. Expansion Cohort 4: Must have documented confirmed PD per RECIST v1.1 on a prior treatment regimen containing an anti-PD-1/L1 drug (see Appendix 6 for definition of PD per RECIST v1.1)
  17. Expansion Cohort 7: Must have all of the following:
    1. Received at least 2 doses of an anti-PD-1/L1 therapy, where the last dose of anti-PD-1/L1 therapy was within 6 months of study enrollment (Day 1)
    2. Refractory response, ie, PD occurred within 3 months duration of the start of treatment on anti-PD-1/L1 therapy; OR resistant response, ie, PD occurred beyond 3 months duration of treatment on anti-PD-1/L1 therapy and within 6 months after the last dose of treatment on anti-PD-1/L1 therapy
    3. Documented PD per RECIST v.1.1, which has been confirmed by a second assessment at least 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression

      \.

      \.

      \.

  • 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 EXCLUSION CRITERIA

A patient with any 1 of the following criteria is not eligible for enrollment in the trial:

  • 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) Phase 1 and Phase 2

  1. Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1 therapy) within 3 weeks prior to study enrollment
  2. Received prior radiotherapy within 2 weeks of start of study therapy. A shorter washout period may be permitted after approval by the Medical Monitor.
  3. Received small molecule inhibitor targeted therapy, such as tyrosine kinase inhibitors, within 2 weeks prior to study enrollment
  4. Has not recovered to CTCAE Grade 1 or better from the AEs due to cancer therapeutics prior to study enrollment

    NOTE: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia or Grade 2 AEs that qualify as Grade 2 due to replacement hormonal or steroid therapy are exceptions to this criterion and may qualify for the study with approval by a Dynavax Medical Monitor.

    If a patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to enrollment.

  5. Received a transfusion of blood products (including platelets or red blood cells) or colony-stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to study enrollment
  6. Is expected to require any other form of anti-cancer therapy while in the trial
  7. 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
  8. Positive for active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection as determined by laboratory tests for HBsAg, anti-HBc, and anti-HBs; anti-HCV; and anti-HIV -1/2, respectively
  9. History of or current uveal or ocular or mucosal melanoma
  10. Active infection including cytomegalovirus
  11. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of trial treatment
  12. 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.
  13. Current pneumonitis or history of (non-infectious) pneumonitis that required steroids
  14. An immune-related AE from a previous immunotherapeutic agent that has not resolved to Grade 1 or less prior to study enrollment. The exception is a Grade 2 AE which qualifies as Grade 2 due to replacement steroid therapy which may be allowed with approval by a Dynavax Medical Monitor.
  15. Known active central nervous system metastases or carcinomatous meningitis

    NOTE: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to the first dose of trial treatment and with any neurologic symptoms returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.

  16. Use of any investigational agent within the last 28 days prior to study enrollment
  17. Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
  18. Any other significant medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with trial participation or trial drug administration that may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for this trial
  19. History of sensitivity to any component of SD-101 or hypersensitivity reaction to treatment with a monoclonal antibody and/or any of its excipients
  20. Any known additional malignancy that is progressing or requires active treatment. Exceptions are cutaneous melanoma or HNSCC under study per protocol, or basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy.

    \.

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

  21. Melanoma considered resectable with curative intent
  22. Prior therapy with an anti-PD-1/L1 agent
  23. Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients

    \.

    ~Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 2 and 8 only)

  24. Melanoma considered resectable with curative intent
  25. Any prior combination therapy involving agents given by intratumoral injection that target the innate immune pathway or system such as oncolytic viral or microbial therapy (eg, T-VEC [talimogene laherparepvec]), toll-like receptors (TLR) agonists, STING or RIG-1 and an anti-PD-1/L1 inhibitor

    \.

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

  26. HNSCC considered resectable with curative intent
  27. Prior therapy with an anti-PD-1/L1 agent
  28. Require anticoagulation therapy

    \.

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

  29. HNSCC considered resectable with curative intent
  30. Any prior combination therapy involving agents given by intratumoral injection that target the innate immune pathway or system such as oncolytic viral or microbial therapy (eg, T-VEC), TLR agonists, STING or RIG-1 and an anti-PD-1/L1 inhibitor
  31. Require treatment on anticoagulation therapy
  • 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
Contacts/Locations
Central Contact: Erick Gamelin Teresa Bagulho, MD
Telephone: 510-665- 0470 0436
Central Contact Backup: Robert Janssen, MD
Telephone: 510-665-0414
Felix Garzon, MD
Telephone: 434-951-3342
Study Officials: Antoni Ribas, MD
Principal Investigator
UCLA School of Medicine (Melanoma)
Ezra Cohen, MD
Principal Investigator
UCSD Moores Cancer Center (HNSCC)
Thomas Tüting, MD
Principal Investigator
University Hospital Magdeburg
Locations: United States, Alabama
University of Alabama School of Medicine
[Recruiting]
Birmingham, Alabama, United States, 35294
Principal Investigator: Robert Conry
University of Alabama
[Recruiting]
Birmingham, Alabama, United States, 35294
Principal Investigator: Lisle Nabell
United States, Arizona
University of Arizona Cancer Center
[Recruiting]
Tucson, Arizona, United States, 85721
Contact: Lisa Slayton 520-694-9057 Lslayton@uacc.arizona.edu
Principal Investigator: Montaser Shaheen
United States, California
University of California, Los Angeles
[Recruiting]
Los Angeles, California, United States, 90095
Contact: Jean Kim 310-794-2464 jeank@mednet.ucla.edu
Principal Investigator: Antoni Ribas
Stanford Hospitals and Clinics
[Active, not recruiting]
Palo Alto, California, United States, 94305
Contact: Jee Min Lee 650-497-5240
University of California, San Diego
[Recruiting]
San Diego, California, United States, 92093
Contact: Parissa Shayesteh 858-822-5368 pshayesteh@ucsd.edu
Principal Investigator: Gregory Daniels
UCSF
[Recruiting]
San Francisco, California, United States, 94158
Contact: Audrey Humphries 415-502- 3081 Kyusun.Cha@ucsf.edu 3569
Principal Investigator: Alain Algazi
United States, Colorado
University of Colorado
[Recruiting]
Aurora, Colorado, United States, 80045
Contact: Michelle Carr 720-848-7135 Michelle.L2.Carr@ucdenver.edu
Principal Investigator: Theresa Medina
United States, Florida
Mount Sinai Comprehensive Cancer Center
[ Recruiting Terminated]
Miami Beach, Florida, United States, 33140
Contact: Jose Lutzky, MD 305-535-3300 Jose.lutzky@msmc.com
Contact: Yvonne Enriquez-Nunez 305-674-2625 Yenrique@msmc.com
United States, Georgia
Georgia Cancer Specialists
[Recruiting]
Decatur, Georgia, United States, 30033
Contact: Sally Haislip 770-496-9457
Georgia Cancer Center - Northside Hospital Central Research Department
[Active, not recruiting]
Atlanta, Georgia, United States, 30341
United States, Illinois
Northwestern University
[Active, not recruiting]
Chicago, Illinois, United States, 60208
Contact: Sunandana Chandra Sunandana.chandra@nm.org
United States, Iowa
University of Iowa Healthcare
[Recruiting]
Iowa City, Iowa, United States, 52242
Contact: Teena Davis VanDaele Theresa Hobbs 319- 467-5834 teena-vandaele@uiowa.edu 356-2577
Principal Investigator: Mohammed Milhem
United States, Michigan
University of Michigan
[Recruiting]
Ann Arbor, Michigan, United States, 48109
Contact: Christopher Lao 734-647-8906
Principal Investigator: Christopher Lao
Barbara Ann Karmanos Cancer Institute
[Recruiting]
Detroit, Michigan, United States, 48201
Contact: 313-576-8994 wolgasta@karmanos.org
Principal Investigator: Amy Weise
United States, Nebraska
Nebraska Methodist Hospital
[Recruiting]
Omaha, Nebraska, United States, 68130
Principal Investigator: Ralph Hauke
United States, New Jersey
Atlantic Health
[Recruiting]
Morristown, New Jersey, United States, 07962
Principal Investigator: Eric Whitman
United States, New York
Roswell Park Cancer Institute
[Active, not recruiting]
Buffalo, New York, United States, 14263
Contact: 716-845-5804 suzanne.stack@roswellpark.org
United States, North Carolina
Levine Cancer Institute
[Recruiting]
Charlotte, North Carolina, United States, 28204
Contact: Ashley Franklin 980-442-2315 Ashley.Franklin@carolinashealthcare.org
Principal Investigator: Asim Amin
Duke University Medical Center
[Recruiting]
Durham, North Carolina, United States, 27710
Principal Investigator: April Salama
United States, Ohio
The Christ Hospital
[ Recruiting Terminated]
Cincinnati, Ohio, United States, 45219
University Hospitals Cleveland Medical Center - Seidman Cancer center
[Recruiting]
Cleveland, Ohio, United States, 44106
Principal Investigator: Christopher Hoimes
United States, Oklahoma
Univ. of Okalhoma Health Sciences Center
[Recruiting]
Oklahoma City, Oklahoma, United States, 73104
Contact: Ingrid Block Chelsea Baker 405-271-8777 Ingrid-block@ouhsc.edu
Principal Investigator: Alexandra Ikeguchi
United States, Pennsylvania
Penn State Hershey Medical Center
[Recruiting]
Hershey, Pennsylvania, United States, 17033
Contact: Jennifer Hallman 717-531-5471 jhallman@pennstatehealth.psu.edu
Principal Investigator: Joseph Drabick
United States, South Carolina
Medical University of South Carolina
[ Not yet Recruiting]
Charleston, South Carolina, United States, 29425
Principal Investigator: Terence Day
United States, Texas
Mary Crowley Cancer Research Center
[Recruiting]
Dallas, Texas, United States, 75230
Contact: Amy Jordon 972-566-3000 referral@marycrowley.org Noureen Karimi 214-658-1985
Principal Investigator: Minal Barve
United States, Utah
University of Utah Health Care - Huntsman Cancer institute
[Recruiting]
Salt Lake City, Utah, United States, 84112
Contact: Jacqueline Richards Emily Measom 801- 587-4433 Jacqueline.Richards@hci.utah.edu 585-0431
Principal Investigator: Jason Hunt
United States, Virginia
Inova Schar Cancer Institute
[Recruiting]
Fairfax, Virginia, United States, 22031
Contact: Kelly Jeffords 703-970-6548 Kelly.Jeffords@inova.org
Principal Investigator: Sekwon Jang
United States, West Virginia
West Virginia University
[Recruiting]
Morgantown, West Virginia, United States, 26506
Contact: Carla Ross 304-581-1158 CJROSS@hsc.wvu.edu
Principal Investigator: Mohammed Almubarak
Australia, New South Wales
The Tweed Hospital
[Recruiting]
Tweed Heads, New South Wales, Australia, 2485
Principal Investigator: Ehtesham Abdi
Liverpool Hospital
[Recruiting]
Westmead, New South Wales, Australia, 2170
Principal Investigator: Adam J Cooper
Melanoma Institute
[Recruiting]
Wollstonecraft, New South Wales, Australia, 2065
Principal Investigator: Georgina Long
Australia, South Australia
Adelaide Cancer Centre - Ashford Cancer Centre
[Recruiting]
Kurralta Park, South Australia, Australia, 5037
Principal Investigator: Sarwan Bishnoi
Australia, Western Australia
Hollywood Private Hospital / Affinity Research
[Recruiting]
Nedlands, Western Australia, Australia
Principal Investigator: Alex Powell
Germany
Charité - Universitätsmedizin Berlin
[ Not yet Recruiting]
Berlin, Germany
Principal Investigator: Felix Kiecker
Klinikum Buxtehude BuxtehudeDermato-Onkologie Studienzentrale
[ Not yet Recruiting]
Buxtehude, Germany
Principal Investigator: Peter Mohr
Universitätsklinikum Dresden
[Recruiting]
Dresden, Germany
Uniklinikum Dresden Klinik und Poliklinik für Dermatologie
[Recruiting]
Dresden, Germany
Principal Investigator: Friedegund Meier
Universitätshautklinik Frankfurt
[Recruiting]
Frankfurt, Germany
Principal Investigator: Roland Kaufmann
Medizinische Hochschule Hannover
[Recruiting]
Hannover, Germany
Principal Investigator: Ralf Gutzmer
HNO-Universitätsklinik Jena
[Recruiting]
Jena, Germany
Principal Investigator: Orlando Guntinas-Lichius
Universitätshautklinik Magdeburg
[Recruiting]
Magdeburg, Germany
Principal Investigator: Thomas Tüting
Universitätsklinikum Regensburg
[ Not yet Recruiting]
Regensburg, Germany
Principal Investigator: Sebastian Haferkamp
Universitätsklinikum Tübingen
[Recruiting]
Tubingen, Germany
Principal Investigator: Claus Garbe
New Zealand
Auckland City Hospital
[Recruiting]
Auckland, New Zealand, 1023
Principal Investigator: Sanjeev Deva
Christchurch Hospital
[Recruiting]
Christchurch, New Zealand, 4710
Principal Investigator: Mathew Strother
Waikato Hospital
[Recruiting]
Hamilton, New Zealand, 3204
Principal Investigator: Michael Jameson
IPDSharing
Plan to Share IPD: Yes
Data will be shared under guidance of the New Rule - FDAAA 801 eff. Jan 2017. 3/2017 - additional changes forthcoming.
Supporting Information:
Time Frame:
Access Criteria:
URL:
References
Citations: Ribas A, Medina T, Kummar S, Amin A, Kalbasi A, Drabick JJ, Barve M, Daniels GA, Wong DJ, Schmidt EV, Candia AF, Coffman RL, Leung ACF, Janssen RS. SD-101 in Combination with Pembrolizumab in Advanced Melanoma: Results of a Phase Ib, Multicenter Study. Cancer Discov. 2018 Oct;8(10):1250-1257. doi: 10.1158/2159-8290.CD-18-0280. Epub 2018 Aug 28. PubMed 30154193
Links:
Available IPD/Information:

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