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Monoclonal Antibodies

Envafolimab + Ipilimumab for Sarcoma (ENVASARC Trial)

Phase 2
Recruiting
Research Sponsored by Tracon Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed locally advanced or metastatic undifferentiated pleomorphic sarcoma (UPS) or grade ≥ 2 myxofibrosarcoma (MFS)
Eastern Cooperative Oncology Group performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 months
Awards & highlights

ENVASARC Trial Summary

This trial is testing a new drug for people with a certain type of cancer that has progressed after one or two rounds of chemotherapy.

Who is the study for?
This trial is for adults with advanced sarcoma, specifically undifferentiated pleomorphic sarcoma or myxofibrosarcoma, who have tried chemotherapy before. They should be relatively healthy otherwise and not have had more than two prior chemo treatments, active hepatitis, brain metastases, recent major surgery, severe lung problems or other serious health issues.Check my eligibility
What is being tested?
The study tests envafolimab alone or combined with ipilimumab in patients whose cancer has worsened after chemotherapy. It's an open-label study where everyone knows what treatment they're getting; participants are divided into different groups to compare the effects of these drugs.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs, skin rash or itching. There might also be fatigue, diarrhea or colitis (inflammation of the colon), liver enzyme changes and potential hormonal gland problems.

ENVASARC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is a specific type called UPS or high-grade MFS.
Select...
I am fully active or can carry out light work.
Select...
My cancer has worsened after chemotherapy.

ENVASARC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 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) by RECIST 1.1 assessed by blinded independent central review
Secondary outcome measures
Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab
Characterize ipilimumab PK in patients given ipilimumab with envafolimab
Characterize the immunogenicity of envafolimab and ipilimumab
+6 more

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

ENVASARC Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort DExperimental Treatment2 Interventions
Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 600 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.
Group II: Cohort CExperimental Treatment1 Intervention
Patients treated with 600 mg of single agent envafolimab every three weeks
Group III: Cohort BExperimental Treatment2 Interventions
Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 300 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.
Group IV: Cohort AExperimental Treatment1 Intervention
Patients treated with 300 mg of single agent envafolimab every three weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Envafolimab
2022
Completed Phase 2
~40
Ipilimumab
2014
Completed Phase 3
~2620

Find a Location

Who is running the clinical trial?

Tracon Pharmaceuticals Inc.Lead Sponsor
21 Previous Clinical Trials
824 Total Patients Enrolled
Charles Theuer, MD, PhDStudy DirectorTracon Pharmaceuticals Inc.
4 Previous Clinical Trials
77 Total Patients Enrolled

Media Library

Envafolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04480502 — Phase 2
Pleomorphic Sarcoma Research Study Groups: Cohort C, Cohort D, Cohort A, Cohort B
Pleomorphic Sarcoma Clinical Trial 2023: Envafolimab Highlights & Side Effects. Trial Name: NCT04480502 — Phase 2
Envafolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04480502 — Phase 2

Frequently Asked Questions

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

Has Envafolimab been cleared by the FDA?

"There is some data supporting the safety of Envafolimab, but none yet for efficacy. Our team gives it a score of 2."

Answered by AI

How many patients are a part of this experiment?

"To proceed with the study, a total of 230 eligible patients are required. The sponsor, Tracon Pharmaceuticals Inc., will be running the trial from several locations; two examples being Johns Hopkins University in Baltimore and University of Michigan in Ann Arbor."

Answered by AI

Are investigators looking for more participants at this time?

"That is correct, the online clinicaltrials.gov database indicates that this trial is currently recruiting patients. This particular study was posted on December 9th 2020 and was last updated on March 31st 2022. They are looking for a total of 230 participants at 29 different locations."

Answered by AI

What other medical studies have there been with Envafolimab?

"Envafolimab was first studied in 2009 by the team at Texas Children's Hospital. In the 11 years since, there have been a total of 189 completed clinical trials worldwide. Right now, 337 different medical centres are actively recruiting patients for envafolimab trials. Many of these locations are in Baltimore, Maryland."

Answered by AI

What are Envafolimab's most common therapeutic applications?

"Envafolimab can help patients with cutaneous melanoma, as well as those who have undergone complete resection or are struggling with metastatic melanoma or liver carcinoma."

Answered by AI

How many areas are responsible for handling this clinical trial?

"Enrollment for this clinical trial is currently open at 29 sites. If you wish to enroll, it may be helpful to choose a location nearest you from the list of participating centres, which include Baltimore, Ann Arbor and Saint Louis, amongst others."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
2020. "ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04480502.
~6 spots leftby Jun 2024
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