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Fachinformation
JOURNAL ONKOLOGIE – STUDIE

Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)

Rekrutierend

NCT-Nummer:
NCT04303169

Studienbeginn:
Juni 2020

Letztes Update:
06.07.2021

Wirkstoff:
Pembrolizumab, V937, Vibostolimab

Indikation (Clinical Trials):
Melanoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Merck Sharp & Dohme Corp.

Collaborator:
-

Studienleiter

Medical Director
Study Director
Merck Sharp & Dohme Corp.

Kontakt

Studienlocations
(3 von 23)

Oregon Health & Science University ( Site 3013)
97239 Portland
United StatesAbgeschlossen» Google-Maps
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Studien-Informationen

Brief Summary:

Substudy 02C is part of a larger research study that is testing experimental treatments for

melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02C is to evaluate the safety and efficacy of investigational treatment

arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to

identify the investigational agent(s) that, when used in combination, are superior to the

current treatment options/historical control available.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Has histologically or cytologically confirmed melanoma

- Has clinically detectable and resectable Stage IIIB or IIIC or IIID melanoma amenable

to surgery

- Has been untreated for Stage IIIB, IIIC or IIID melanoma

- surgical resection of primary melanoma is allowed

- prior radiotherapy to the primary melanoma is allowed

- Has provided a baseline tumor biopsy

- Male participants who receive V937 are abstinent from heterosexual intercourse or

agree to use contraception during the intervention period and for at least 120 days

after the last dose of V937

- Female participants are not pregnant or breastfeeding and are either not a woman of

child-bearing potential (WOCBP) OR use a contraceptive method that is highly effective

or are abstinent from heterosexual intercourse during the intervention period and for

at least 120 days after the last dose of pembrolizumab, vibostolimab, V937, whichever

occurs last

- Has adequate organ function

- Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less

(except alopecia)

Exclusion Criteria:

- Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7

days before the first dose of study intervention

- Has a known additional malignancy that is progressing or requires active treatment

within the past 2 years

- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis

- Has ocular or mucosal melanoma

- Has known hypersensitivity including previous clinically significant hypersensitivity

reaction to treatment with another monoclonal antibody (mAb)

- Has an active autoimmune disease that has required systemic treatment in the past 2

years

- Has an active infection requiring systemic therapy

- Has known history of human immunodeficiency virus (HIV)

- Has known history of hepatitis B

- Has a history of (noninfectious) pneumonitis

- Has a history of active tuberculosis (TB)

- Has received prior systemic anticancer therapy within 4 weeks prior to randomization

- Has received prior radiotherapy within 2 weeks of first dose of study intervention

- Has had major surgery <3 weeks prior to first dose of study intervention

- Has received a live vaccine within 30 days before the first dose of study intervention

- Has participated in a study of an investigational agent within 4 weeks prior to the

first dose of study intervention

- Has had an allogeneic tissue/solid organ transplant

- Has only mucosal lesions

- Is not naïve to Talimogene laherparepvec (TVEC) and other oncolytic viruses

Studien-Rationale

Primary outcome:

1. Percentage of participants who experience an adverse event (AE) (Time Frame - Up to ~16 months):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience an AE will be reported.

2. Percentage of participants who discontinue study treatment due to an AE (Time Frame - Up to ~12 months):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.

3. Pathological complete response (pCR) rate (Time Frame - Up to ~1.5 months):
pCR rate is defined as the proportion of participants with complete absence of viable tumor in the treated tumor bed. Assessments are according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by central review of the pathology results. RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Secondary outcome:

1. Near pathological complete response (near pCR) rate (Time Frame - Up to ~1.5 months):
Near pCR is defined as the proportion of participants with >0% but ≤10% of viable tumor cells in the treated tumor bed. Assessments are according to RECIST 1.1 by central review of the pathology results. RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

2. Pathological partial response (pPR) rate (Time Frame - Up to ~1.5 months):
pPR rate is defined as the proportion of participants with >10% but ≤50% of the treated tumor bed occupied by viable tumor cells. Assessments are according to RECIST 1.1 by central review of the pathology results. RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

3. Recurrence-free survival (RFS) (Time Frame - Up to ~60 months):
RFS is defined as the time from the date of surgery to (1) any recurrence (local, regional, or distant) as assessed by the investigator or (2) death due to any cause (both cancer and noncancer causes of death). Assessments are according to RECIST 1.1 which has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Studien-Arme

  • Experimental: Pembrolizumab + Vibostolimab
    Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab intravenously (IV) plus vibostolimab IV at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.
  • Experimental: Pembrolizumab + V937
    Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV plus V937 intratumorally (IT) at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.
  • Experimental: Pembrolizumab
    Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Geprüfte Regime

  • Pembrolizumab (MK-3475 / KEYTRUDA® / ):
    Administered via IV infusion at a specified dose on specified days
  • Vibostolimab (MK-7684):
    Administered via IV infusion at a specified dose on specified days
  • V937 (Coxsackievirus A21 (CVA21) / Formerly known as CAVATAK® / CAV21 / ):
    Administered via IT injection at a specified dose on specified days

Quelle: ClinicalTrials.gov


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