NC410 + Pembrolizumab for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: NextCure, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

Research Team

Udayan Guha, MD

Principal Investigator

NextCure, Inc.

Eligibility Criteria

Adults with advanced unresectable/metastatic solid tumors, including specific cancers like colorectal, stomach, esophageal, and ovarian. Participants must have progressed after standard therapy or be ICI refractory. They should agree to contraception use and not expect a child soon. Adequate organ function and an ECOG status of 0-1 are required.

Inclusion Criteria

My cancer is not highly mutated and has worsened after treatment.

My organs are functioning well.

My cancer is advanced, cannot be surgically removed, and may have spread.

Exclusion Criteria

I have or had lung inflammation that needed steroids.

I am currently being treated for an infection.

I have received a transplant from another person.

Treatment Details

Interventions

• NC410 (Monoclonal Antibodies)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview The trial is testing the combination of NC410 with Pembrolizumab for safety, tolerability, and effectiveness in treating various advanced solid tumors that are either resistant to immune checkpoint inhibitors (ICIs) or haven't been treated with ICIs if they're microsatellite stable/low.

Participant Groups

Group I: NC410 and pembrolizumab Experimental Treatment 2 Interventions

All participants will receive NC410 (IV) and pembrolizumab (IV) according to the treatment schedule until a reason for treatment discontinuation is reached.

Who Is Running the Clinical Trial?

NextCure, Inc.

Lead Sponsor

Trials

8

Recruited

660+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University