Principales Criterios de Inclusión:
- Part 1 only: Has histologically-or cytologically-confirmed advanced/metastatic solid tumors and have received, been intolerant to, or been ineligible for, all treatments known to confer clinical benefit. Sites are encouraged to enroll patients with the following tumor types known to have relatively high levels of ILT3 expression or have myeloid-rich tumor microenvironment: NSCLC, melanoma, CCRCC, pancreatic cancer, TNBC, and mesothelioma.
- Has measurable disease by RECIST 1.1 (RANO for Cohort B) as assessed by the local site investigator/radiology. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Has provided an evaluable archival or newly obtained (to be processed as FFPE) tumor tissue sample. FFPE blocks are preferred to slides. Details pertaining to tumor tissue submission can be found in the Procedures Manual.
- Part 1, Arm 1 only: Has 1 or more discrete malignant lesions that are amenable to biopsy.
- Has an ECOG performance status of 0 to 1 assessed within 72 hours (Part 1) or 7 days (Part 2) before the start of study treatment.
- Participant is Male or Female of at least 18 years of age on the day of signing the informed consent.
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 95 days after the last dose of chemotherapy:
• Refrain from donating sperm
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on long-term and persistent basis) and agree to remain abstinent
• Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause documented from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview) as detailed below:
- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
o Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
• Is not a WOCBP
• Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least 180 days after the last dose of chemotherapy or 120 days after the last dose of MK-0482 or pembrolizumab, whichever occurs last. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
– Part 2 Cohorts A, C, and E only: WOCBP must also agree not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during and for at least 180 days after the last dose of chemotherapy.
– A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours (for urine) or 72 hours (for serum) before the first dose of study intervention.
– If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Abstains from breastfeeding during the study intervention period and for at least 180 days after the last dose of chemotherapy or 120 days after the last dose of MK-0482 or pembrolizumab, whichever occurs last. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
- Área Terapéutica:Oncología
- Fase del estudio:Ib
- Código de Estudio:MK0482-001
- Ver ensayo en Clinical Trials
- Bradford Hill
- Centro de Investigación y Desarollo Oncologico (CIDO)