Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment
NCT ID: NCT03132675
Last Updated: 2023-03-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
143 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-03
Study Completion Date
2024-07-31
Brief Summary
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Keynote 695 is Phase 2 study of intratumoral tavokinogene telseplasmid (tavo; pIL-12) Electroporation (EP) plus IV Pembrolizumab. Eligible patients will be those with pathological diagnosis of unresectable or metastatic melanoma who are progressing or have progressed on either pembrolizumab or nivolumab.
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Detailed Description
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The study will be comprised of a screening period, a treatment period (up to 2 years), a long term follow-up period, and a survival follow-up period.
Eligible subjects will be treated with TAVO-EP to the accessible lesions on days 1, 5, and 8 every 6 weeks and with IV pembrolizumab (200 mg) on Day 1 of each 3-week cycle for up to 18 TAVO-EP cycles and 35 pembrolizumab cycles (from baseline) of continued treatment (approximately 2 years) or until disease progression. As many accessible lesions may be treated, as deemed feasible by the treating physician, as long as the size of each lesion is greater than 0.3 cm × 0.3 cm.
Long-term Follow-up: All subjects will be followed after End of Treatment (EOT) visit for SAEs (through 90 days from last dose of study drug). Subjects who discontinue treatment will enter the long-term follow-up period unless they have started a new anti-cancer therapy (or other local anticancer immunotherapy) or have withdrawn consent for non-survival assessments. They will have scans, photographs, and investigator-assessed disease evaluation per RECIST v1.1 collected every 3 months until disease progression, or the subject receives a new systemic anti-cancer treatment (or other local anticancer immunotherapy).
Survival Follow-up: Once a subject receives a new systemic anti-cancer treatment (or other local anticancer immunotherapy), they will move into survival follow-up. All subjects will be followed for survival and disease status, every 3 months up to a total duration of 5 years, withdrawal of consent, or until Sponsor terminates the study.
Eligible subjects will be treated with TAVO-EP to the accessible lesions on days 1, 5, and 8 every 6 weeks and with IV pembrolizumab (200 mg) on Day 1 of each 3-week cycle for up to 18 TAVO-EP cycles and 35 pembrolizumab cycles (from baseline) of continued treatment (approximately 2 years) or until disease progression. As many accessible lesions may be treated, as deemed feasible by the treating physician, as long as the size of each lesion is greater than 0.3 cm × 0.3 cm.
Long-term Follow-up: All subjects will be followed after End of Treatment (EOT) visit for SAEs (through 90 days from last dose of study drug). Subjects who discontinue treatment will enter the long-term follow-up period unless they have started a new anti-cancer therapy (or other local anticancer immunotherapy) or have withdrawn consent for non-survival assessments. They will have scans, photographs, and investigator-assessed disease evaluation per RECIST v1.1 collected every 3 months until disease progression, or the subject receives a new systemic anti-cancer treatment (or other local anticancer immunotherapy).
Survival Follow-up: Once a subject receives a new systemic anti-cancer treatment (or other local anticancer immunotherapy), they will move into survival follow-up. All subjects will be followed for survival and disease status, every 3 months up to a total duration of 5 years, withdrawal of consent, or until Sponsor terminates the study.
Conditions
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Stage III/IV Melanoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Cohort 1A\_Locally advanced/metastatic melanoma: pathological diagnosis of unresectable or metastatic melanoma with progression on pembrolizumab or nivolumab, confirmed according to RECIST v1.1. BRAF V600 mutation-positive melanoma could have received standard of care targeted therapy for advanced or metastatic disease (eg, BRAF/MEK inhibitor, alone or in combination) prior to enrolling on this study; however, progression is not required.
Cohort 1B\_Locally advanced/metastatic melanoma: Subjects will be enrolled in order to collect safety data using the GenPulse generator. Eligibility for enrollment will be the same as that for Cohort 1A.
Cohort 2\_Locally advanced/metastatic melanoma with prior exposure to ipilimumab alone or in combination with nivolumab (or other drug(s)/agent(s)): Eligible subjects will be those with pathological diagnosis of unresectable or metastatic melanoma who have been exposed to ipilimumab alone or in combination with nivolumab (or other drug/agent)
Cohort 1B\_Locally advanced/metastatic melanoma: Subjects will be enrolled in order to collect safety data using the GenPulse generator. Eligibility for enrollment will be the same as that for Cohort 1A.
Cohort 2\_Locally advanced/metastatic melanoma with prior exposure to ipilimumab alone or in combination with nivolumab (or other drug(s)/agent(s)): Eligible subjects will be those with pathological diagnosis of unresectable or metastatic melanoma who have been exposed to ipilimumab alone or in combination with nivolumab (or other drug/agent)
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Blinded Independent Central Review
Study Groups
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tavo-EP plus IV pembrolizumab
Intratumoral Tavokinogene Telseplasmid (tavo, pIL 12) plus Electroporation (ImmunoPulse) in Combination with Intravenous Pembrolizumab
Group Type
EXPERIMENTAL
tavokinogene telseplasmid
Intervention Type
BIOLOGICAL
Intratumoral tavokinogene telseplasmid (tavo, pIL-12) delivered by electroporation every 6 weeks
Pembrolizumab
Intervention Type
BIOLOGICAL
Intravenous 3 weekly treatments
ImmunoPulse
Intervention Type
DEVICE
Device that electroporates the tavokinogene telseplasmid
Interventions
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tavokinogene telseplasmid
Intratumoral tavokinogene telseplasmid (tavo, pIL-12) delivered by electroporation every 6 weeks
Intervention Type
BIOLOGICAL
Pembrolizumab
Intravenous 3 weekly treatments
Intervention Type
BIOLOGICAL
ImmunoPulse
Device that electroporates the tavokinogene telseplasmid
Intervention Type
DEVICE
Other Intervention Names
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pIL-12
tavo-EP
Keytruda
tavo-EP
Eligibility Criteria
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Inclusion Criteria
In order to be eligible for participation in this study, the subject must meet all of the following:
All Cohorts:
1. Pathologically documented unresectable melanoma, American Joint Committee on Cancer (AJCC) version 8, Stage III or IV. Subjects must have histological or cytological confirmed diagnosis of unresectable melanoma with progressive locally advanced or metastatic disease.
2. Subjects must be refractory to anti-PD-1 monoclonal antibodies (mAb) (pembrolizumab or nivolumab either as monotherapy or in combination with other approved checkpoint inhibitors or targeted therapies according to their approved label) and subjects must meet all of the following criteria:
1. Received treatment of FDA-approved anti-PD1 mAb (dosed per label of the country providing the clinical site) for at least 12 weeks (eg, 4 administrations of q3w 200 mg pembrolizumab or 2 administrations of q6w 400 mg pembrolizumab).
2. Progressive disease after anti-PD-1 mAb will be defined according to RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment, no less than 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression. For cases of rapid clinical progression, patients may be allowed to enroll without a confirmatory scan after discussion with the sponsor. (This determination is made by the Investigator; the Sponsor will collect imaging scans for retrospective analysis. Once PD is confirmed, the initial date of PD documentation will be considered the date of disease progression).
3. Documented disease progression within 12 weeks of the last dose of anti- PD-1 mAb. Subjects who were re-treated with anti-PD-1 mAb and subjects who were on maintenance with anti-PD-1 mAb will be allowed to enter the study as long as there is documented PD within 12 weeks of the last treatment date (with anti-PD-1 mAb).
Note: anti-PD-1 combination therapy is acceptable as the last prior treatment and may include, anti-PD-1 anti-CTLA4 antibody combination therapy and anti-PD-1 combinations with investigational or injectable therapy.
Cohort 2:
3. Subjects must have received ipilimumab alone or in combination with nivolumab (or another agent) within approximately 12 months and must meet the following criteria:
1. Subject received 4 doses of ipilimumab (alone or in combination) or stopped treatment due to treatment-related adverse event, or investigator determined that the risks of further exposure outweigh the benefits.
2. Subjects with rapid clinical progression after fewer than 4 doses may be allowed after discussion with the sponsor.
All Cohorts:
4. Resolution/improvement of anti-PD-1 mAb related adverse events (including immune related AEs; irAEs) back to Grade 0-1 and ≤10 mg/day prednisone (or equivalent dose) for irAEs for at least 2 weeks prior to the first dose of study drug:
1. No history of common toxicity criteria adverse events (CTCAE) Grade 4 irAEs from anti-PD-1 mAb.
2. No history of CTCAE Grade 3 requiring steroid treatment (\>10 mg/day prednisone or equivalent dose) for \>12 weeks or CTCAE Grade 2 pneumonitis regardless of steroid treatment. No history of (non-infectious) pneumonitis or interstitial lung disease that required steroids, and no current pneumonitis or interstitial lung disease.
3. Minimum of 4 weeks (washout period) from the last dose of anti-PD-1 mAb
5. BRAF V600 mutation-positive melanoma could have received standard of care targeted therapy for advanced or metastatic disease (eg, BRAF/MEK inhibitor, alone or in combination) prior to enrolling on this study; however they do not need to have progressed on this treatment.
6. Age ≥ 18 years of age on day of signing informed consent.
7. Has a performance status of 0 or 1 on the ECOG Performance Scale, collected within 7 days of initial treatment.
8. Have measurable disease based on RECIST v1.1, with at least one anatomically distinct lesion. At least one lesion must meet all the following baseline criteria:
1. Accessible for electroporation;
2. Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) Note: Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
9. Demonstrate adequate organ function. All screening laboratories should be performed within 10 days of treatment initiation.
10. Women of childbearing potential must have negative pregnancy test (for serum or urine pregnancy test, within 72 hours or 24 hours, respectively, prior to receiving the first study drug administration). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
11. For women of childbearing potential, must be willing to use an adequate method of contraception from the first day of study treatment (or 14 days prior to the initiation of study treatment for oral contraception) and through at least 120 days following last day of study treatment. Acceptable methods include hormonal contraception (oral contraceptives
\- as long as on stable dose, patch, implant, and injection), intrauterine devices, or double barrier methods (eg, vaginal diaphragm/ vaginal sponge plus condom, or condom plus spermicidal jelly), sexual abstinence or a vasectomized partner. Women may be surgically sterile or at least 1-year post-last menstrual period. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Note: Spermicide alone is not considered sufficient and will not be accepted
12. Male subjects must be surgically sterile or must agree to use adequate method of contraception when having sex with women of childbearing potential and refrains from sperm donation during the study treatment period and through at least 120 days following the last day of study drug administration.. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
13. Able and willing to provide written informed consent and to follow study instructions.
All Cohorts:
1. Pathologically documented unresectable melanoma, American Joint Committee on Cancer (AJCC) version 8, Stage III or IV. Subjects must have histological or cytological confirmed diagnosis of unresectable melanoma with progressive locally advanced or metastatic disease.
2. Subjects must be refractory to anti-PD-1 monoclonal antibodies (mAb) (pembrolizumab or nivolumab either as monotherapy or in combination with other approved checkpoint inhibitors or targeted therapies according to their approved label) and subjects must meet all of the following criteria:
1. Received treatment of FDA-approved anti-PD1 mAb (dosed per label of the country providing the clinical site) for at least 12 weeks (eg, 4 administrations of q3w 200 mg pembrolizumab or 2 administrations of q6w 400 mg pembrolizumab).
2. Progressive disease after anti-PD-1 mAb will be defined according to RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment, no less than 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression. For cases of rapid clinical progression, patients may be allowed to enroll without a confirmatory scan after discussion with the sponsor. (This determination is made by the Investigator; the Sponsor will collect imaging scans for retrospective analysis. Once PD is confirmed, the initial date of PD documentation will be considered the date of disease progression).
3. Documented disease progression within 12 weeks of the last dose of anti- PD-1 mAb. Subjects who were re-treated with anti-PD-1 mAb and subjects who were on maintenance with anti-PD-1 mAb will be allowed to enter the study as long as there is documented PD within 12 weeks of the last treatment date (with anti-PD-1 mAb).
Note: anti-PD-1 combination therapy is acceptable as the last prior treatment and may include, anti-PD-1 anti-CTLA4 antibody combination therapy and anti-PD-1 combinations with investigational or injectable therapy.
Cohort 2:
3. Subjects must have received ipilimumab alone or in combination with nivolumab (or another agent) within approximately 12 months and must meet the following criteria:
1. Subject received 4 doses of ipilimumab (alone or in combination) or stopped treatment due to treatment-related adverse event, or investigator determined that the risks of further exposure outweigh the benefits.
2. Subjects with rapid clinical progression after fewer than 4 doses may be allowed after discussion with the sponsor.
All Cohorts:
4. Resolution/improvement of anti-PD-1 mAb related adverse events (including immune related AEs; irAEs) back to Grade 0-1 and ≤10 mg/day prednisone (or equivalent dose) for irAEs for at least 2 weeks prior to the first dose of study drug:
1. No history of common toxicity criteria adverse events (CTCAE) Grade 4 irAEs from anti-PD-1 mAb.
2. No history of CTCAE Grade 3 requiring steroid treatment (\>10 mg/day prednisone or equivalent dose) for \>12 weeks or CTCAE Grade 2 pneumonitis regardless of steroid treatment. No history of (non-infectious) pneumonitis or interstitial lung disease that required steroids, and no current pneumonitis or interstitial lung disease.
3. Minimum of 4 weeks (washout period) from the last dose of anti-PD-1 mAb
5. BRAF V600 mutation-positive melanoma could have received standard of care targeted therapy for advanced or metastatic disease (eg, BRAF/MEK inhibitor, alone or in combination) prior to enrolling on this study; however they do not need to have progressed on this treatment.
6. Age ≥ 18 years of age on day of signing informed consent.
7. Has a performance status of 0 or 1 on the ECOG Performance Scale, collected within 7 days of initial treatment.
8. Have measurable disease based on RECIST v1.1, with at least one anatomically distinct lesion. At least one lesion must meet all the following baseline criteria:
1. Accessible for electroporation;
2. Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) Note: Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
9. Demonstrate adequate organ function. All screening laboratories should be performed within 10 days of treatment initiation.
10. Women of childbearing potential must have negative pregnancy test (for serum or urine pregnancy test, within 72 hours or 24 hours, respectively, prior to receiving the first study drug administration). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
11. For women of childbearing potential, must be willing to use an adequate method of contraception from the first day of study treatment (or 14 days prior to the initiation of study treatment for oral contraception) and through at least 120 days following last day of study treatment. Acceptable methods include hormonal contraception (oral contraceptives
\- as long as on stable dose, patch, implant, and injection), intrauterine devices, or double barrier methods (eg, vaginal diaphragm/ vaginal sponge plus condom, or condom plus spermicidal jelly), sexual abstinence or a vasectomized partner. Women may be surgically sterile or at least 1-year post-last menstrual period. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Note: Spermicide alone is not considered sufficient and will not be accepted
12. Male subjects must be surgically sterile or must agree to use adequate method of contraception when having sex with women of childbearing potential and refrains from sperm donation during the study treatment period and through at least 120 days following the last day of study drug administration.. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
13. Able and willing to provide written informed consent and to follow study instructions.
Exclusion Criteria
1. Subject has disease that is suitable for local therapy administered with curative intent.
2. Clinically active CNS metastases. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study drug.
3. Subject with a diagnosis of uveal or mucosal melanoma.
4. Subject with clinically unstable or uncontrolled secondary malignancy that is progressing, or requires active treatment are excluded. In addition, subjects who have had a secondary malignancy that has resolved within the last 6 months, are also excluded.
5. Subject who had an allogenic tissue/solid organ transplant.
6. Subjects who have had intervening therapy following confirmed progression on anti-PD-1 therapy or anti-PD-1 combination therapy with the exception of BRAF inhibitors or BRAF/MEK inhibitor combinations.
Note: anti-PD-1 combination therapy is acceptable as the last prior treatment and may include, anti-PD-1 anti-CTLA4 antibody combination therapy and anti-PD-1 combinations with investigational or injectable therapy.
7. Subjects who have received 4 or more lines of prior therapy, may be allowed to enroll after discussion with the Medical Monitor.
8. Subjects with electronic pacemakers or defibrillators.
9. Subjects who have a known history of Human Immunodeficiency Virus (HIV) (HIV1/2 antibodies). HIV-infected subjects with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
10. Subjects who have a known history of Hepatitis B or C infections or known to be positive for Hepatitis B antigen (HBsAg) or Hepatitis B virus (HBV) DNA or active. Active Hepatitis C. Active Hep C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay
11. Subject has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
12. Subjects who have received a live-virus or live-attenuated vaccination within 30 days of the first dose of treatment. Note: Administration of killed vaccines are allowed. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
13. Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
14. Subject has a history of (non infectious) pneumonitis or interstitial lung disease that required steroids or has current pneumonitis or interstitial lung disease.
15. Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
16. Subject has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent, excluding thyroid, hypo adrenal, and diabetes if well controlled.
Note: Subjects with ≤Grade 2 neuropathy or ≤Grade 2 alopecia and hypopigmentation are an exception to this criterion and may qualify for the study.
Note: Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible if approved by the Sponsor.
Note: If subject underwent major surgery or radiation therapy of \>30 Gy within 2 weeks of enrollment, they must have recovered adequately from the procedure and/or any complications from the intervention prior to starting study combination therapy.
17. Participation in another clinical study of an investigational anti-cancer agent or has used an investigational device within 30 days of screening.
Note: Subjects participating in an observational or supportive care study are an exception to this criterion and may qualify for the study with Sponsor approval.
Note: Subjects who have entered the follow up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent.
18. Subject has known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
19. Subjects who are pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
2. Clinically active CNS metastases. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study drug.
3. Subject with a diagnosis of uveal or mucosal melanoma.
4. Subject with clinically unstable or uncontrolled secondary malignancy that is progressing, or requires active treatment are excluded. In addition, subjects who have had a secondary malignancy that has resolved within the last 6 months, are also excluded.
5. Subject who had an allogenic tissue/solid organ transplant.
6. Subjects who have had intervening therapy following confirmed progression on anti-PD-1 therapy or anti-PD-1 combination therapy with the exception of BRAF inhibitors or BRAF/MEK inhibitor combinations.
Note: anti-PD-1 combination therapy is acceptable as the last prior treatment and may include, anti-PD-1 anti-CTLA4 antibody combination therapy and anti-PD-1 combinations with investigational or injectable therapy.
7. Subjects who have received 4 or more lines of prior therapy, may be allowed to enroll after discussion with the Medical Monitor.
8. Subjects with electronic pacemakers or defibrillators.
9. Subjects who have a known history of Human Immunodeficiency Virus (HIV) (HIV1/2 antibodies). HIV-infected subjects with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
10. Subjects who have a known history of Hepatitis B or C infections or known to be positive for Hepatitis B antigen (HBsAg) or Hepatitis B virus (HBV) DNA or active. Active Hepatitis C. Active Hep C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay
11. Subject has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
12. Subjects who have received a live-virus or live-attenuated vaccination within 30 days of the first dose of treatment. Note: Administration of killed vaccines are allowed. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
13. Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
14. Subject has a history of (non infectious) pneumonitis or interstitial lung disease that required steroids or has current pneumonitis or interstitial lung disease.
15. Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
16. Subject has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent, excluding thyroid, hypo adrenal, and diabetes if well controlled.
Note: Subjects with ≤Grade 2 neuropathy or ≤Grade 2 alopecia and hypopigmentation are an exception to this criterion and may qualify for the study.
Note: Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible if approved by the Sponsor.
Note: If subject underwent major surgery or radiation therapy of \>30 Gy within 2 weeks of enrollment, they must have recovered adequately from the procedure and/or any complications from the intervention prior to starting study combination therapy.
17. Participation in another clinical study of an investigational anti-cancer agent or has used an investigational device within 30 days of screening.
Note: Subjects participating in an observational or supportive care study are an exception to this criterion and may qualify for the study with Sponsor approval.
Note: Subjects who have entered the follow up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent.
18. Subject has known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
19. Subjects who are pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Sponsor Role
collaborator
OncoSec Medical Incorporated
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Bridget O'Keeffe, PhD
Role: STUDY_DIRECTOR
OncoSec Medical Incorporated
Locations
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The University of Arizona Cancer Center
Tucson, Arizona, United States
Site Status
Yuma Regional Medical Center, Yuma Cancer Center
Yuma, Arizona, United States
Site Status
University of California, San Diego
La Jolla, California, United States
Site Status
UCSF Medical Center
San Francisco, California, United States
Site Status
University of Colorado Anschutz Medical Campus University of Colorado Cancer Center
Aurora, Colorado, United States
Site Status
University of Miami Sylvester Cancer Center
Miami, Florida, United States
Site Status
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States
Site Status
Moffit Cancer Center
Tampa, Florida, United States
Site Status
Ochsner Cancer Institute
New Orleans, Louisiana, United States
Site Status
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
University of Michigan, Michigan Medicine Melanoma Oncology Clinic - Rogel Cancer Center
Ann Arbor, Michigan, United States
Site Status
Dartmouth Hitchcock Clinic
Lebanon, New Hampshire, United States
Site Status
Atlantic Health System
Morristown, New Jersey, United States
Site Status
Roswell Park Cancer Institute
Buffalo, New York, United States
Site Status
Health Quest Systems, Inc.
Poughkeepsie, New York, United States
Site Status
Duke University
Durham, North Carolina, United States
Site Status
Gabrail Cancer Center
Canton, Ohio, United States
Site Status
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Site Status
Penn State Health Hershey Medical Center
Hershey, Pennsylvania, United States
Site Status
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Site Status
Texas Oncology/Baylor
Dallas, Texas, United States
Site Status
Houston Methodist Cancer Center
Houston, Texas, United States
Site Status
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Site Status
Westmead Hospital
Westmead, New South Wales, Australia
Site Status
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Site Status
Cavalry Central Districts Hospital
Elizabeth Vale, South Australia, Australia
Site Status
Box Hill Hospital
Box Hill, Victoria, Australia
Site Status
The Alfred Hospital
Melbourne, Victoria, Australia
Site Status
St John of God Hospital
Subiaco, Western Australia, Australia
Site Status
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Site Status
McGill University Health Centre
Montreal, Quebec, Canada
Site Status
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, , Italy
Site Status
University of Zurich, Dermatology Clinic
Zurich, Canton of Zurich, Switzerland
Site Status
Countries
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United States
Australia
Canada
Italy
Switzerland
References
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Jacobs L, Yshii L, Junius S, Geukens N, Liston A, Hollevoet K, Declerck P. Intratumoral DNA-based delivery of checkpoint-inhibiting antibodies and interleukin 12 triggers T cell infiltration and anti-tumor response. Cancer Gene Ther. 2022 Jul;29(7):984-992. doi: 10.1038/s41417-021-00403-8. Epub 2021 Nov 9.
Reference Type
DERIVED
Other Identifiers
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Keynote-695
Identifier Type: OTHER
Identifier Source: secondary_id
MK3475-695
Identifier Type: OTHER
Identifier Source: secondary_id
OMS-I103 (KEYNOTE 695)
Identifier Type: -
Identifier Source: org_study_id
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NCT04526730
ACTIVE_NOT_RECRUITING
PHASE2
Pembrolizumab Effects on NK Cell Exhaustion in Melanoma (Merck NK-IIT)
NCT03241927
TERMINATED
PHASE2
A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
NCT05665595
COMPLETED
PHASE3
Nivolumab, BMS-936558 in Combination with Relatlimab, BMS-986016 in Patients with Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting
NCT03743766
COMPLETED
PHASE2
Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
NCT03553836
ACTIVE_NOT_RECRUITING
PHASE3
Ipilimumab With Carboplatin and Paclitaxel in Patients With Unresectable Stage III and Stage IV Melanoma
NCT01676649
ACTIVE_NOT_RECRUITING
PHASE2
Ipilimumab vs Ipilimumab Plus Nivolumab in Patients With Stage III-IV Melanoma Who Have Progressed or Relapsed on PD-1 Inhibitor Therapy
NCT02731729
COMPLETED
PHASE2
Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).
NCT04068181
COMPLETED
PHASE2
Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma
NCT02073123
COMPLETED
PHASE1/PHASE2
A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
NCT06961006
RECRUITING
PHASE2
Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma
NCT03276832
COMPLETED
EARLY_PHASE1
Pembrolizumab and Ibrutinib in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
NCT03021460
ACTIVE_NOT_RECRUITING
PHASE1
BO-112 With Pembrolizumab in Unresectable Malignant Melanoma
NCT04570332
COMPLETED
PHASE2
Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma
NCT06580054
RECRUITING
PHASE2
An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
NCT03068455
COMPLETED
PHASE3
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
NCT03698019
ACTIVE_NOT_RECRUITING
PHASE2
Pembrolizumab With Carboplatin/Paclitaxel in Patients With Metastatic Melanoma
NCT02617849
ACTIVE_NOT_RECRUITING
PHASE2
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
NCT05297565
COMPLETED
PHASE3
Neoadjuvant Combination Immunotherapy for Stage III Melanoma
NCT03842943
RECRUITING
PHASE2
Study of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-041/KEYNOTE-041)
NCT02180061
COMPLETED
PHASE1
Ipilimumab and Nivolumab Followed by Adjuvant Nivolumab in Locally Advanced or Limited Metastatic Melanoma
NCT06566391
ACTIVE_NOT_RECRUITING
PHASE2
Immune Predictors of Response to Pembrolizumab Therapy in Stage IV Melanoma Patients
NCT02744209
TERMINATED
IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
NCT05155254
ACTIVE_NOT_RECRUITING
PHASE3
Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)
NCT03407170
TERMINATED
PHASE2