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Monoclonal Antibodies

Etigilimab + Nivolumab for Metastatic Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Mereo BioPharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months.
Awards & highlights

Study Summary

This trial is testing a new drug, etigilimab, to see if it is safe and effective when used with another drug, nivolumab, to treat subjects with locally advanced or metastatic solid tumors.

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors who can't have curative surgery or radiation. They must have a tumor diagnosis confirmed by lab tests, tissue available for study, stable organ function, and an expected lifespan of over 12 weeks. Participants should be fairly active (ECOG status 0-1) and not pregnant, using reliable contraception if necessary.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: Etigilimab and Nivolumab in patients with serious tumor conditions. It's an early phase trial to check how well these drugs work together, their safety levels, and how the body responds to them when given every two weeks.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system since both drugs are designed to activate it against cancer cells. This might lead to inflammation in various organs, fatigue, potential infusion-related reactions like fever or chills, as well as increased risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

8Treatment groups
Experimental Treatment
Group I: Tumor burden high (TMB-H) and microsatellite stable (MSS) solid tumorsExperimental Treatment2 Interventions
Advanced or metastatic tumor mutational burden-high (TMB-H)
Group II: Squamous cell carcinoma of the head and neckExperimental Treatment2 Interventions
Advanced and/or recurrent or metastatic squamous cell carcinoma of the head and neck
Group III: Rare disease with high prevalence of TIGIT expressionExperimental Treatment2 Interventions
Select rare tumors
Group IV: Ovarian cancerExperimental Treatment2 Interventions
Recurrent high grade serous and endometrioid ovarian cancer, fallopian tube cancer or primary peritoneal cancer following front-line platinum-based therapy
Group V: Gastric or gastroesophageal junction adenocarcinomaExperimental Treatment2 Interventions
Recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
Group VI: Endometrial carcinoma post-platinum <3L treatmentExperimental Treatment2 Interventions
Advanced and/or metastatic endometrial carcinoma
Group VII: Endometrial carcinoma post standard of care therapyExperimental Treatment2 Interventions
Advanced and/or metastatic endometrial carcinoma
Group VIII: Cervical cancer on or after chemotherapyExperimental Treatment2 Interventions
Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etigilimab dosing
2021
Completed Phase 2
~80
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

ICON Clinical ResearchIndustry Sponsor
49 Previous Clinical Trials
15,296 Total Patients Enrolled
Mereo BioPharmaLead Sponsor
22 Previous Clinical Trials
1,646 Total Patients Enrolled

Media Library

Etigilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04761198 — Phase 1 & 2
Solid Tumors Research Study Groups: Cervical cancer on or after chemotherapy, Ovarian cancer, Tumor burden high (TMB-H) and microsatellite stable (MSS) solid tumors, Endometrial carcinoma post-platinum <3L treatment, Rare disease with high prevalence of TIGIT expression, Gastric or gastroesophageal junction adenocarcinoma, Endometrial carcinoma post standard of care therapy, Squamous cell carcinoma of the head and neck
Solid Tumors Clinical Trial 2023: Etigilimab Highlights & Side Effects. Trial Name: NCT04761198 — Phase 1 & 2
Etigilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04761198 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any historical accounts of Etigilimab dosages?

"Etigilimab administration was initially researched in 2012 at Local Institution. Of the 252 studies that have been concluded, 718 remain active with a majority of them being conducted in Houston, Texas."

Answered by AI

Is the enrollment process still open for this experiment?

"Affirmative. Per information accessible on clinicaltrials.gov, this trial is actively seeking participants with the initial listing being posted on March 23rd 2021 and last modified June 6th of 2022. The study requires 125 individuals to be recruited from 14 sites."

Answered by AI

What is the size of the cohort being assessed in this clinical research?

"Affirmative. According to clinicaltrials.gov, the trial which commenced on March 23rd 2021 is still actively seeking participants. 125 individuals from 14 different sites are necessary for this study's completion."

Answered by AI

At what geographic locations is this experiment currently being conducted?

"This trial is presently enrolling patients at 14 centres, located in cities such as Houston, New york and Nashville. To reduce travel-related complications for potential participants, it's advisable to select the medical centre nearest you."

Answered by AI

Is this trial pioneering a new methodology in medical research?

"Etigilimab dosing has been the focus of scientific enquiry since 2012, with Ono Pharmaceutical Co. Ltd sponsoring its first trial involving 659 participants. Subsequently gaining Phase 1 and 2 drug approval, Etigilimab is now being investigated in 718 trials across 49 countries and 2354 cities."

Answered by AI

To what disorders is Etigilimab typically administered?

"Etigilimab is frequently prescribed to treat malignant neoplasms but can also be used to manage cases of unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors.
2021. "A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04761198.
~19 spots leftby Apr 2025
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