This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks).
Recruiting
Phase 1/Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Etigilimab dosing | MPH313 | Cervical cancer on or after chemotherapy |
| Nivolumab | Opdivo | Cervical cancer on or after chemotherapy |
This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy,
safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in
subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to
receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks) and
will continue until either unacceptable toxicity or disease progression. Subjects may
continue to receive treatment beyond documented RECIST 1.1 or disease progression. Subjects
who are both CPI (checkpoint inhibitor) naïve as well as subjects who have received or
progressed following a CPI will be eligible and include the following tumor types: head and
neck squamous cell carcinoma (HNSCC), cervical carcinoma, gastric or gastroesophageal
carcinoma, endometrial carcinoma, tumor mutation burden high (TMB-H), select rare tumors and
ovarian carcinoma.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Squamous cell carcinoma of the head and neck | Experimental | Advanced and/or recurrent or metastatic squamous cell carcinoma of the head and neck |
|
| Cervical cancer on or after chemotherapy | Experimental | Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 |
|
| Gastric or gastroesophageal junction adenocarcinoma | Experimental | Recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma |
|
| Endometrial carcinoma post-platinum <3L treatment | Experimental | Advanced and/or metastatic endometrial carcinoma |
|
| Tumor burden high (TMB-H) and microsatellite stable (MSS) solid tumors | Experimental | Advanced or metastatic tumor mutational burden-high (TMB-H) |
|
| Rare disease with high prevalence of TIGIT expression | Experimental | Select rare tumors |
|
| Ovarian cancer | Experimental | Recurrent high grade serous and endometrioid ovarian cancer, fallopian tube cancer or primary peritoneal cancer following front-line platinum-based therapy |
|
| Endometrial carcinoma post standard of care therapy | Experimental | Advanced and/or metastatic endometrial carcinoma |
|
Inclusion Criteria:
- Histological or cytological diagnosis of a relevant tumor type as per the study
protocol and not candidates for curative surgery or radiation therapy
- Available tumor tissue (archival or newly obtained core or excisional biopsy)
- Adequate hematologic and end organ function as measured by laboratory screening panel
in the 14 days prior to treatment
- Life expectancy greater than 12 weeks.
- ECOG performance status of 0 to 1
- Adequate contraception for women of childbearing potential
- Pre-specified wash-out of prior anti-PD1/PDL-1 therapy
Exclusion Criteria:
- Concurrent active malignancy
- Major surgery within 4 weeks of treatment
- Subjects with active, known or suspected autoimmune diseases
- Prior treatment with CD137 agonists, anti-CTLA-4 and anti-TIGIT antibodies
- History of any Grade 3 or 4 immune-related AE toxicity from prior immunotherapy that
resulted in treatment discontinuation
- History of immune-related adverse events that lead to discontinuation of anti-PD-1 or
PDL-1 therapy
- Active infections of HIV, hepatitis B, hepatitis C
- Medical illness or abnormal laboratory finding that would, in the Study Investigator's
judgement, increase the risk to the subject associated with participation in the study
- Pregnancy in female subjects
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Objective Response Rate (ORR) |
| Time Frame: | Approximately 24 months. |
| Safety Issue: | |
| Description: | The ORR is the proportion of subjects whose best response rate (BOR) is confirmed CR or confirmed PR radiographically according to RECISTv1.1. Where BOR is defined as the best investigator-assessed confirmed response during the time period. |
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Mereo BioPharma |
August 2, 2021
