Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

  • STATUS
    Recruiting
  • End date
    Jul 15, 2024
  • participants needed
    390
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 16 April 2021

Summary

Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

Details
Condition Renal Cell Carcinoma, Renal Cell Cancer
Treatment Pembrolizumab, Lenvatinib, MK-4280, Belzutifan, Quavonlimab
Clinical Study IdentifierNCT04626479
SponsorMerck Sharp & Dohme Corp.
Last Modified on16 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 120 yrs?
Gender: Male or Female
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Has a histologically confirmed diagnosis of locally advanced/metastatic ccRCC
Has received no prior systemic therapy for advanced RCC; prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed 12 months before randomization/allocation
Is able to swallow oral medication
Has adequate organ function
Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks before randomization/allocation
Has resolution of toxic effects of the most recent prior therapy to Grade 1
If participants receive major surgery or radiation therapy, they must have recovered from complications from the intervention
Has adequately controlled blood pressure (BP 150/90 mm Hg) with no change in hypertensive medications within 1 week before randomization/allocation
Male participants are abstinent from heterosexual intercourse or agree to use contraception during treatment with and for at least 7 days after the last dose of lenvatinib and /or belzutifan; 7 days after lenvatinib and/or belzutifan is stopped, if the participant is only receiving pembrolizumab, pembrolizumab/quavonlimab, MK-4280A or a combination of the aforementioned drugs, no contraception is needed
Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the last dose of pembrolizumab, pembrolizumab/quavonlimab, MK-4280A or 30 days after the last dose of lenvatinib or belzutifan , whichever occurs last

Exclusion Criteria

Has urine protein 1 g/24 hours and has any of the following: (a) hypoxia defined as a pulse oximeter reading <92% at rest, or (b) requires intermittent supplemental oxygen, or (c) requires chronic supplemental oxygen
Has clinically significant cardiovascular disease within 12 months from the first dose of study intervention administration
Has had major surgery within 3 weeks before first dose of study interventions
Has a history of lung disease
Has a history of inflammatory bowel disease
Has preexisting gastrointestinal (GI) or non-GI fistula
Has malabsorption due to prior GI surgery or disease
Has received prior radiotherapy within 2 weeks of start of study intervention
Has received a live or live attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
Has received more than 4 previous systemic anticancer treatment regimens
Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy is not considered a form of systemic treatment and is allowed
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B
Has had an allogenic tissue/solid organ transplant
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note