MK-4884 safety in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 trial evaluating the safety and tolerability of MK-4884 in participants with unresectable or metastatic solid tumors. Eligible cancers include colorectal cancer, certain renal cancers, nonsquamous non-small cell lung cancer, and biliary tract/gallbladder cancers. The study will enroll participants with measurable disease and adequate organ function, including HIV- or HBV-positive individuals under specified control criteria. Dosing cohorts will help determine safe dose levels and potential dose-limiting toxicities. Sites include centers in Missouri, Texas, and Ontario.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has a histologically or cytologically confirmed diagnosis of 1 of the following unresectable (locally advanced) and/or advanced (metastatic) solid tumors:
* Colorectal carcinoma (CRC)
* Renal cell carcinoma (RCC) that contains a clear cell component (with or without sarcomatoid and/or rhabdoid features)
* Nonsquamous non-small cell lung cancer (NSCLC)
* Biliary tract cancer (BTC) (intra-or extrahepatic cholangiocarcinoma (CCA)) or gallbladder cancer (GBC)
* Has measurable disease by Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1)
* Has adequate organ function
* Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable antiretroviral therapy (ART) for at least 4 weeks
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

* Has gastrointestinal malabsorption, a surgical procedure or a condition that could affect the absorption of the study drug
* Has a history of clinically significant cardiac, cardiovascular and/or cerebrovascular disease
* Has a serious nonhealing wound, ulcer, or bone fracture
* Has an active infection(s) requiring systemic therapy
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has a history of stem cell/solid organ transplant
* Has not adequately recovered from major surgery

Where it's running

• Siteman Cancer Center ( Site 0153)
  St Louis, Missouri, United States Recruiting
• NEXT Oncology ( Site 0151)
  San Antonio, Texas, United States Recruiting
• Princess Margaret Cancer Centre ( Site 0004)
  Toronto, Ontario, Canada Recruiting
• Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0002)
  Montreal, Quebec, Canada Recruiting
• Rambam Health Care Campus ( Site 0051)
  Haifa, Israel Recruiting
• Rabin Medical Center ( Site 0053)
  Petah Tikva, Israel Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MK-2010 with Sac-TMT in advanced solid tumors

  This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.

  Recruiting at 4 sites Phase 2 Merck Sharp & Dohme LLC · San Antonio, Texas and 3 other locations · NCT07785609

• Belzutifan in adolescents with solid tumors

  This study tests belzutifan in teenagers whose solid tumors can't be removed by surgery or have spread.

  Recruiting at 10 sites Phase 2 Merck Sharp & Dohme LLC · Iowa City, Iowa and 9 other locations · NCT07700758

• Ifinatamab Deruxtecan in kids with relapsed or refractory solid cancers

  This study tests whether I-DXd can help children whose solid tumors have come back or not responded to previous treatments.

  Recruiting at 35 sites Phase 1/2 Merck Sharp & Dohme LLC · Los Angeles, California and 34 other locations · NCT07630974

• PET scan targeting CDH3 for lung tumors

  This will test whether a new PET imaging agent called 68Ga-TOI-1 that targets CDH3 can better detect and stage lung tumors and help tell malignant from benign pulmonary nodules in adults with suspected or confirmed non-small cell lung cancer.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07487883

• Dabrafenib and trametinib for rare cancers with BRAF V600 mutations

  This arm tests whether dabrafenib and trametinib can help adults, children, and teens with cancers that have a BRAF V600 mutation.

  Recruiting at 15 sites Phase 2/3 Cancer Research UK · Belfast and 26 other locations · NCT07440290

• Pembrolizumab treatment for Japanese children with solid tumors or lymphomas and Japanese adults with Merkel cell carcinoma

  This study will try pembrolizumab in Japanese children with solid tumors or lymphomas and in Japanese adults with Merkel cell carcinoma to learn about safety, how the drug moves through the body, and whether tumors shrink.

  Recruiting at 7 sites Phase 1/2 Merck Sharp & Dohme LLC · Nagoya, Aichi-ken and 6 other locations · NCT07302347

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.