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Advanced/Metastatic MelanomaPhase 2NCT04152863

Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)

A Phase 2 study testing Gebasaxturev IV, Gebasaxturev ITu and Pembrolizumab in people with Advanced/Metastatic Melanoma, run by Merck Sharp & Dohme LLC at 30 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced/Metastatic Melanoma
What is being tested?
Gebasaxturev IV, Gebasaxturev ITu and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
30 sitesin 11 countries
Study dates
5 Jun 2020to 12 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has histologically or cytologically confirmed diagnosis of advanced/metastatic melanoma.
  • Has Stage III or Stage IV melanoma.
  • Must be naive to anti-PD-L1 treatment, talimogene laherparepvec (TVEC) and other oncolytic viruses.
  • Has 2 lesions as defined below:
  • At least 1 cutaneous or subcutaneous lesion that is amenable to IT injection and biopsy and measurable per RECIST 1.1
  • At least 1 distant and/or discrete noninjected lesion that is amenable to biopsy and measurable per RECIST 1.1
Show all 17Show fewer
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • Demonstrates adequate organ function
  • Male participants refrain from donating sperm during the intervention period and for at least 120 days after the last dose of study intervention PLUS are either abstinent from heterosexual intercourse OR agree to use approved contraception during that period
  • Female participants are not pregnant or breastfeeding and are not a woman of childbearing potential (WOCBP) OR are a WOCBP that agrees to use contraception during the treatment and for at least 120 days after the last dose of study intervention
  • Has measurable disease per RECIST 1.1
  • Is able to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART), defined as:
  • Must have Cluster of Differentiation 4 (CD4)+ T-cell count >350 cells/mm^3 at time of screening
  • Must have achieved and maintained virologic suppression
  • Must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry
  • The combination ART regimen must not contain any antiretroviral medication other than abacavir, dolutegravir, emtricitabine, lamivudine, raltegravir, rilpivirine, or tenofovir

Who cannot join

  • Has had chemotherapy, definitive radiation, or biological cancer therapy or an investigational agent or investigational device within 4 weeks prior to the first dose of study intervention or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
  • Has ocular melanoma
  • Has radiographic evidence of major blood vessel infiltration
  • Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Show all 23Show fewer
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the study requirements
  • Has undergone allogeneic hematopoietic stem cell transplantation within the last 5 years
  • Has not fully recovered from major surgery without significant detectable infection
  • Active cardiovascular disease (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure or serious cardiac arrhythmia requiring medication
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other agents such as cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), OX-40, Cluster of Differentiation 137 (CD137)
  • Has received a live vaccine within 30 days prior to the first dose of study drug
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in excess of replacement doses or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has hypersensitivity to pembrolizumab and/or any of its excipients
  • Has hypersensitivity to gebasaxturev or any of its excipients
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has had an allogenic tissue/solid organ transplant

Trial locations and contacts

30 sites in 11 countries.

30 sites in 11 countries

South Africa5 sites

  • Cape Town Oncology Trials Pty Ltd ( Site 0104)

    Cape Town, Western Cape, 7570

  • WITS Clinical Research CMJAH Clinical Trial Site ( Site 0101)

    Johannesburg, Gauteng, 2193

  • Clinical Research Unit - University of Pretoria ( Site 0102)

    Pretoria, Gauteng, 0002

  • Wilgers Oncology Centre ( Site 0103)

    Pretoria, Gauteng, 0081

  • Little Company of Mary Hospital ( Site 0100)

    Pretoria, Gauteng, 0181

Other trials in South Africa

United States4 sites

  • Henry Ford Hospital ( Site 0008)

    Detroit, Michigan, 48202

  • Rutgers Cancer Institute of New Jersey ( Site 0002)

    New Brunswick, New Jersey, 08903

  • Providence Portland Medical Center [Portland, OR] ( Site 0005)

    Portland, Oregon, 97213

  • Northwest Medical Specialties, PLLC ( Site 0006)

    Tacoma, Washington, 98405

Other trials in United States

Australia3 sites

  • Alfred Health ( Site 0142)

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital ( Site 0141)

    Murdoch, Western Australia, 6150

  • The Queen Elizabeth Hospital ( Site 0143)

    Woodville, South Australia, 5011

Other trials in Australia

Germany3 sites

  • Universitaetsklinikum Leipzig AOeR ( Site 2005)

    Leipzig, Saxony, 04103

  • Universitaetsklinikum Regensburg ( Site 2007)

    Regensburg, Bavaria, 93053

  • Universitaetsklinikum Tuebingen-Hautklinik ( Site 2001)

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Israel3 sites

  • Rambam Health Care Campus-Oncology Division ( Site 0040)

    Haifa, 3109601

  • Hadassah Ein Kerem Medical Center ( Site 0042)

    Jerusalem, 9112001

  • Chaim Sheba Medical Center ( Site 0041)

    Ramat Gan, 5262000

Other trials in Israel

Spain3 sites

  • Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0088)

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Clinica Universitaria de Navarra. ( Site 0082)

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Valencia ( Site 0090)

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

Chile2 sites

  • FALP-UIDO ( Site 2062)

    Santiago, Region M. de Santiago, 6900941

  • Bradfordhill-Clinical Area ( Site 2061)

    Santiago, Region M. de Santiago, 8420383

Other trials in Chile

France2 sites

  • Centre Georges Francois Leclerc ( Site 2025)

    Dijon, Cote-d Or, 21079

  • CHU de Grenoble Hopital Nord ( Site 2027)

    La Tronche, Isere, 38700

Other trials in France

Italy2 sites

  • Istituto Europeo di Oncologia ( Site 2040)

    Milan, 20141

  • Policlinico Le Scotte - A.O. Senese ( Site 2039)

    Siena, 53100

Other trials in Italy

South Korea2 sites

  • Seoul National University Hospital ( Site 1992)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 1993)

    Seoul, 03722

Other trials in South Korea

Norway1 site

  • Oslo Universitetssykehus Radiumhospitalet ( Site 0060)

    Oslo, 0424

Other trials in Norway

About this study

Official title: A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma

This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that gebasaxturev administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone. This study will be terminated once all participants finish treatment with V937. Participants eligible to continue to receive pembrolizumab will be transferred to MK-3475-587 study.

Being tested
Gebasaxturev IV, Gebasaxturev ITu, Pembrolizumab
Keywords
programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1), programmed cell death ligand 2 (PD-L2, PDL2), Coxsackievirus A21, Intracellular Adhesion Molecule-1 (ICAM-1)
Medical subject headings
Melanoma, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gebasaxturev IVBiological

    Also called Coxsackievirus A21 (CVA21), Formerly known as CAVATAK®, CAV21, V937

    Administered as an IV infusion of 1 X 10^9 TCID50

  • Gebasaxturev ITuBiological

    Also called Coxsackievirus A21 (CVA21), Formerly known as CAVATAK®, CAV21, V937

    Administered as an ITu injection of 3 X 10^8 TCID50

  • PembrolizumabDrug

    Also called MK-3475, Keytruda®

    Administered as an IV infusion of 200 mg

Study groups in NCT04152863
Study groupRoleWhat they receive
IV Gebasaxturev + PembrolizumabExperimentalParticipants receive gebasaxturev at a dose of 1 X 10^9 TCID50 by IV infusion on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev will be administered for up to 8 cycles (up to 6 months). Pembrolizumab will be administered for up to 35 cycles (up to 2 years).
Receives: Biological: Gebasaxturev IV; Drug: Pembrolizumab
ITu Gebasaxturev + PembrolizumabExperimentalParticipants receive gebasaxturev at a dose of 3 X 10^8 TCID50 by ITu injection on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev will be administered for up to 8 cycles (up to 6 months). Pembrolizumab will be administered for up to 35 cycles (up to 2 years).
Receives: Biological: Gebasaxturev ITu; Drug: Pembrolizumab
PembrolizumabExperimentalParticipants receive pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab will be administered for up to 35 cycles (up to 2 years).
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    ORR was defined as the percentage of participants who experienced a Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, without evidence of progression based on non-target or new lesions) as assessed by BICR per RECIST 1.1 which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 is presented.

    Measured: Up to ~ 35 months

Secondary outcomes (8)

  1. Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD.

    Measured: Up to ~ 35 months

  2. Duration of Response (DOR)

    For participants who demonstrated a confirmed complete response (CR: disappearance of all lesions) or confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, without evidence of progression based on non-target or new lesions.) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. RECIST 1.1 was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ and was assessed by BICR for this outcome measure.

    Measured: Up to ~ 35 months

  3. Objective Response Rate (ORR) Per RECIST 1.1, as Assessed by the Investigator

    ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by the investigator modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 was presented.

    Measured: Up to ~ 35 months

  4. Progression Free Survival (PFS) RECIST 1.1, as Assessed by the Investigator

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 as assessed by the investigator, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD.

    Measured: Up to ~ 35 months

  5. Duration of Response (DOR) Per RECIST 1.1, as Assessed by the Investigator

    For participants who demonstrated a confirmed complete response (CR: disappearance of all lesions) or confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death.

    Measured: Up to ~ 35 months

  6. Overall Survival (OS)

    OS is the time from randomization to death due to any cause.

    Measured: Up to ~ 35 months

  7. Percentage of Participants Who Experienced an Adverse Event (AE)

    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Measured: Up to ~ 37 months

  8. Percentage of Participants Who Discontinued Study Drug Due to an AE

    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Measured: Up to ~ 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start5 Jun 2020
  3. Primary completion12 Jul 2023
  4. Study completion12 Jul 2023

Why it stopped: Business Reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04152863
Sponsor's protocol ID
V937-011
Other IDs
V937-011, 2019-002034-36, 2019
Status last verified
Jul 2024
First submitted
4 Nov 2019
Last updated
6 Aug 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Deng JZ, Rustandi RR, Barbacci D, Swartz AR, Gulasarian A, Loughney JW. Reverse-Phase Ultra-Performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification. Hum Gene Ther. 2022 Jul;33(13-14):765-775. doi: 10.1089/hum.2022.013. Epub 2022 Jun 1.

    PubMed 35387488

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gebasaxturev IV, Gebasaxturev ITu and Pembrolizumab in people with Advanced/Metastatic Melanoma, run by Merck Sharp & Dohme LLC at 30 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in South Africa, United States, Australia, Germany, Israel and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to ~ 35 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04152863, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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