Phase 2 ICI Naïve Cohort 2b for Head Neck Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Head Neck Cancer+21 More
NC410 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Immune Checkpoint Inhibitor Refractory
  • Immune Checkpoint Inhibitor Naïve
  • Microsatellite Stable
  • Advanced or Metastatic Solid Tumors
  • Ovarian Cancer
  • Microsatellite Instability High
  • Head Neck Cancer
  • Microsatellite Instability Low
  • Colorectal Carcinoma
  • Endometrial Cancer
  • Malignant Neoplasm of Stomach
  • Esophageal Neoplasms Malignant
  • Cervical Cancers
  • Lung Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 24 Months

24 Months
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
42 days
Define a recommended Phase 2 dose (RP2D) of NC410 when combined with standard dose Pembrolizumab
Month 24
Disease Control Rate per RECIST
Duration of Response per RECIST
Objective Response Rate per RECIST
Progression-free Survival (PFS) per RECIST

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

Phase 2 ICI Naïve Cohort 2b
1 of 6
Phase 2 ICI Naïve Cohort 2c
1 of 6
Phase 2 ICI Naïve Cohort 2a
1 of 6
Phase 1b
1 of 6
Phase 2 ICI Refractory Cohort 1
1 of 6
NC410 and Pembrolizumab
1 of 6

Experimental Treatment

131 Total Participants · 6 Treatment Groups

Primary Treatment: Phase 2 ICI Naïve Cohort 2b · No Placebo Group · Phase 1 & 2

Phase 2 ICI Naïve Cohort 2bExperimental Group · 2 Interventions: NC410, Pembrolizumab · Intervention Types: Drug, Drug
Phase 2 ICI Naïve Cohort 2cExperimental Group · 2 Interventions: NC410, Pembrolizumab · Intervention Types: Drug, Drug
Phase 2 ICI Naïve Cohort 2aExperimental Group · 2 Interventions: NC410, Pembrolizumab · Intervention Types: Drug, Drug
Phase 1bExperimental Group · 2 Interventions: NC410, Pembrolizumab · Intervention Types: Drug, Drug
Phase 2 ICI Refractory Cohort 1Experimental Group · 2 Interventions: NC410, Pembrolizumab · Intervention Types: Drug, Drug
NC410 and PembrolizumabExperimental Group · 2 Interventions: NC410, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2580

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,658 Previous Clinical Trials
4,955,011 Total Patients Enrolled
1 Trials studying Head Neck Cancer
241 Patients Enrolled for Head Neck Cancer
NextCure, Inc.Lead Sponsor
5 Previous Clinical Trials
548 Total Patients Enrolled
Han Myint, MDStudy DirectorNextCure, Inc.
3 Previous Clinical Trials
407 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received at least 2 doses of an approved anti-PD-1/L1 mAb.
You have demonstrated disease progression after PD-1/L1 as defined by RECIST v1.1.
You have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
You are able to provide tumor tissue sample at Screening, archival (≤ 5 years old) or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: November 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.