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A Phase 1/2 Study of MK-2870 plus EV plus Pembrolizumab in la/mUC
EU CTIS ID: 2023-506387-14-00
What this study is testing
1. Part 1: To evaluate the safety and tolerability of MK-2870 in combination with EV 2. Not applicable: Part 2: To evaluate the safety and tolerability of MK-2870 in combination with pembrolizumab and EV 3. Not applicable: Part 2: To evaluate ORR, per RECIST 1.1 based on investigator assessment, of MK-2870 in combination with pembrolizumab and EV
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC).
- Must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation. A newly obtained biopsy is strongly preferred, but not required if archival tissue is evaluable.
- Any AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Endocrine-related AEs adequately treated with hormone replacement are eligible.
- PART 1 ONLY: Participants must have received platinum-based chemotherapy for treatment of la/mUC.
- PART 1 ONLY: Participants must not have received >2 lines of therapy for la/mUC. Platinum-based chemotherapy followed by avelumab maintenance is considered 2 lines of therapy.
- Not applicable: PART 2 ONLY: Participants must not have received prior systemic therapy for la/mUC.
You likely can't join if
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
- Not applicable: PART 2 ONLY: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
- Not applicable: PART 2 ONLY: Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
- Is human immunodeficiency virus (HIV)-infected and has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- Has active Hepatitis B or Hepatitis C virus infection.
See the full eligibility criteria
- Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC).
- Must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation. A newly obtained biopsy is strongly preferred, but not required if archival tissue is evaluable.
- Any AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Endocrine-related AEs adequately treated with hormone replacement are eligible.
- PART 1 ONLY: Participants must have received platinum-based chemotherapy for treatment of la/mUC.
- PART 1 ONLY: Participants must not have received >2 lines of therapy for la/mUC. Platinum-based chemotherapy followed by avelumab maintenance is considered 2 lines of therapy.
- Not applicable: PART 2 ONLY: Participants must not have received prior systemic therapy for la/mUC.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
- Not applicable: PART 2 ONLY: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
- Not applicable: PART 2 ONLY: Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
- Is human immunodeficiency virus (HIV)-infected and has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- Has active Hepatitis B or Hepatitis C virus infection.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Not applicable: PART 2 ONLY: History of allogeneic tissue/solid organ transplant.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Has Grade ≥2 peripheral neuropathy.
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease and/or serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
- Has active keratitis or corneal ulcerations. Superficial punctate keratitis is allowed if the disorder is being adequately treated in the opinion of the investigator.
- Has a history of uncontrolled diabetes.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- United States
- Korea, Republic of
- United Kingdom
- Israel
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; United States; Korea, Republic of; United Kingdom; Israel; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.