Informations générales (source: ClinicalTrials.gov)
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02B
Interventional
Phase 1/Phase 2
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
juillet 2020
avril 2030
27 juillet 2025
Substudy 02B is part of a larger research study where researchers are looking for new
ways to treat advanced melanoma that has not been treated before. The larger study is the
umbrella study. Researchers want to know if adding other treatments to pembrolizumab can
treat advanced melanoma. The goals of this study are to learn:
- About the safety and how well people tolerate pembrolizumab given with other
treatments
- How many people have melanoma that responds (gets smaller or goes away) to treatment
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline ROBERT | 06/03/2024 11:08:06 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| A.P.H. Paris, Hopital Saint Louis ( Site 2107) - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| C.H. Lyon Sud ( Site 2102) - 69495 - Pierre Benite - Rhone - France | Contact (sur clinicalTrials) | ||||
| CHU de Bordeaux- Hopital Saint Andre ( Site 2108) - 33075 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| Hopital La Timone ( Site 2103) - 13005 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud ( Site 2105) - 31059 - Toulouse cedex 9 - Haute-Garonne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- If capable of producing sperm, male participants agree to the following during the
intervention period and for at least the time needed to eliminate each study
intervention after the last dose of study intervention (7 days):
- Abstains from penile-vaginal intercourse as their preferred and usual lifestyle
(abstinent on a long-term and persistent basis) and agrees to remain abstinent
OR
- Uses contraception unless confirmed to be azoospermic
- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and at least one of the following conditions applies:
- Is not a WOCBP OR
- Is a WOCBP and Uses a contraceptive method that is highly effective, with low
user dependency, or be abstinent from penile-vaginal intercourse as their
preferred and usual lifestyle (abstinent on a long-term and persistent basis)
during the intervention period and for at least the time needed to eliminate
each study intervention after the last dose of study intervention. The length
of time required to continue contraception for each study intervention is:
- MK-4280A: 120 days
- MK-1308A: 120 days
- MK-7684: 50 days
- MK-3475: 120 days
- Lenvatinib: 30 days
- ATRA: 30 days
- 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)
- 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
- If capable of producing sperm, male participants agree to the following during the
intervention period and for at least the time needed to eliminate each study
intervention after the last dose of study intervention (7 days):
- Abstains from penile-vaginal intercourse as their preferred and usual lifestyle
(abstinent on a long-term and persistent basis) and agrees to remain abstinent
OR
- Uses contraception unless confirmed to be azoospermic
- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and at least one of the following conditions applies:
- Is not a WOCBP OR
- Is a WOCBP and Uses a contraceptive method that is highly effective, with low
user dependency, or be abstinent from penile-vaginal intercourse as their
preferred and usual lifestyle (abstinent on a long-term and persistent basis)
during the intervention period and for at least the time needed to eliminate
each study intervention after the last dose of study intervention. The length
of time required to continue contraception for each study intervention is:
- MK-4280A: 120 days
- MK-1308A: 120 days
- MK-7684: 50 days
- MK-3475: 120 days
- Lenvatinib: 30 days
- ATRA: 30 days
- 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)
- 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 history of Hepatitis B or known Hepatitis C virus infection
- 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
- Participants who receive lenvatinib have the following additional exclusion
criteria:
- Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula
- Has radiographic evidence of encasement of invasion of a major blood vessel, or
of intratumoral cavitation
- Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to
the first dose of study intervention
- Has clinically significant cardiovascular disease within 12 months from first
dose of study intervention
- Has urine protein ≥1 g/24-hour.
- Has presence of gastrointestinal condition including malabsorption,
gastrointestinal anastomosis, or any other condition that might affect the
absorption of lenvatinib