Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

MK-1084 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Blood / Myeloma / Lymphoma,Bowel (colorectum),Brain and spinal cord,Breast,CUP,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAdrenocortical carcinoma,Anus,Astrocytoma,Basal cell carcinoma,B-Cell Non Hodgkin Lymphoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cancer of Unknown Primary,Central Nervous System,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Diffuse Large Cell Lymphoma,Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Follicular Lymphoma,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastrointestinal stromal tumors (GISTs),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Glioblastoma (GBM) ,Glioma,Head and neck,Hodgkin's Disease (Hodgkin's Lymphoma),Kidney,Langerhans Cell Histiocytosis,Leiomyosarcoma,Liposarcoma,Liver,Lung,Lymphoma,Mantle Cell Lymphoma,Medullablastoma,Melanoma (Ocular),Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Mouth (including tonsil, tongue, soft palate, cheeks, lips, gum),Neuroblastoma,Neuroendocrine tumours,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Paroxysmal Nocturnal Hemoglobinuria (PNH),Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Skin Lymphoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Squamous cell carcinoma ,Stomach,Synovial Sarcoma,T-Cell Lymphoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Vagina,Voice box (larynx),Vulva,Wilm's tumour

Trial Overview Read MoreRead more

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 mutation.
 

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

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • 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.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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

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

Commercial Sponsor

Merck

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.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Early Phase Research Study Coordinator
earlyphase.oncresearch@monashhealth.org
0474 769 510

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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