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RecruitingLast updated: 8 April 2024

MK-1084: This phase I trial is evaluating how safe and effective targeted therapy (MK-1084) is alone in people with advanced solid cancers with KRASG12C mutation, and when it is combined with immunotherapy (pembrolizumab) in people with non-small cell cancer with KRASG12C mutationA Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and in Combination With Pembrolizumab in Subjects With KRASG12C Mutant Advanced Solid Tumors

Clinical summary

Summary

Eligible participants will be allocated to one of two arms depending on the type of cancer they have. Participants with advanced solid cancers with KRASG12C mutation will receive MK-1084 daily, orally, in escalating doses. Participants with first line (previously untreated) non-small lung cancer with KRASG12C mutation will receive pembrolizumab plus MK-1084. Pembrolizumab will be administered 200mg via intravenous infusion (IV) once every 21-day cycle. MK-1084 will be administered daily, orally, in escalating doses.

Conditions

This trial is treating patients with non-small cell lung cancer and advanced solid cancers with KRASG12C mutation

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

MK-1084

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Merck

Scientific Title

A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and in Combination With Pembrolizumab in Subjects With KRASG12C Mutant Advanced Solid Tumors

Eligibility

Inclusion

For all participants:

  • Has measurable disease by RECIST 1.1 criteria
  • Has adequate organ function
  • Male participants must be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic
  • Female participants must not be pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child-bearing potential (WOCBP); is a WOCBP and uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention

For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease

For Arm 2

- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%

For Arm 3

  • Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 3L/4L metastatic colorectal cancer (mCRC)
  • Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma with histological or blood-based confirmation of KRAS G12C mutation
  • Previous treatment failure of 2 or 3 previous lines of systemic therapy Expansion Group B
  • Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease

Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation

Arm 5 only

  • Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation
  • Previous treatment failure of one or 2 previous line(s) of systemic therapy

Arm 6 only

- Untreated locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation

Exclusion

  • Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation)
  • Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
  • Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active infection requiring systemic therapy
  • Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus
  • Has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis
  • Has an active autoimmune disease requiring systemic therapy
  • Has not fully recovered from any effects of major surgical procedure without significant detectable infection
  • Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease
  • Has received live or live-attenuated vaccine within 4 weeks of study start

Arm 4 Only

  • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed.
  • Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

Inclusion

  • Your cancer has spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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