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Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

Rekrutierend

NCT-Nummer:
NCT04305054

Studienbeginn:
Juli 2020

Letztes Update:
14.07.2021

Wirkstoff:
Pembrolizumab, Lenvatinib, Vibostolimab, Pembrolizumab/Quavonlimab

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 27)

Oregon Health & Science University ( Site 2013)
97239 Portland
United StatesAbgeschlossen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

Substudy 02B 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 02B is to evaluate the safety and efficacy of investigational treatment

arms in participants with 1L advanced melanoma and to identify the investigational agent(s)

that, when used in combination, are superior to the current treatment options/pembrolizumab

monotherapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Has histologically or cytologically confirmed melanoma

- Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy

- Has been untreated for advanced disease

- Has provided a tumor biopsy

- Male participants are abstinent from heterosexual intercourse or agree to use

contraception during the intervention period and for at least 7 days after the last

dose of lenvatinib; 7 days after lenvatinib is stopped, if participants are on

pembrolizumab, pembrolizumab/quavonlimab, vibostolimab or a combination of the

aforementioned drugs, no additional male contraception measures are needed

- 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, pembrolizumab/quavonlimab,

vibostolimab, or 30 days after the last dose of lenvatinib, 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 and Grade 2 neuropathy)

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 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 a known psychiatric or substance abuse disorder that would interfere with

requirements of the study

Studien-Rationale

Primary outcome:

1. Percentage of participants who experience an adverse event (AE) (Time Frame - Up to ~28 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 ~24 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. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Time Frame - Up to ~30 months):
ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR). 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. Duration of Response (DOR) per RECIST 1.1 (Time Frame - Up to ~30 months):
For participants in the analysis population who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by BICR. 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.

Studien-Arme

  • Experimental: Pembrolizumab + Vibostolimab
    Participants will receive pembrolizumab intravenously (IV) plus vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Active Comparator: Pembrolizumab
    Participants will receive pembrolizumab IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Coformulation Pembrolizumab/Quavonlimab
    Participants will receive coformulation of pembrolizumab and quavonlimab (MK-1308A) IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
    Participants will receive coformulation of pembrolizumab and quavonlimab IV plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.

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
  • Pembrolizumab/Quavonlimab (MK-1308A):
    Administered via IV infusion at a specified dose on specified days
  • Lenvatinib (MK-7902 / E7080 / LENVIMA® / ):
    Administered via oral capsule at a specified dose on specified days

Quelle: ClinicalTrials.gov


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