← Back to Search

Anti-metabolites

Botensilimab + Chemotherapy for Pancreatic Cancer

Phase 2
Recruiting
Research Sponsored by Agenus Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of pancreatic ductal adenocarcinoma
Eastern Cooperative Oncology Group performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial tests if adding a new drug to chemo helps fight metastatic pancreatic cancer better than chemo alone.

Who is the study for?
This trial is for adults with metastatic pancreatic cancer who have already tried FOLFIRINOX treatment. They should be relatively healthy otherwise, with a life expectancy of at least 3 months and able to perform daily activities (ECOG status 0 or 1). Participants must not have other active cancers or serious illnesses, no history of severe allergies to study drugs, and agree to use effective contraception.Check my eligibility
What is being tested?
The study is testing the effectiveness of Botensilimab when added to standard chemotherapy (Gemcitabine and Nab-paclitaxel) versus chemotherapy alone in treating metastatic pancreatic cancer. Patients are divided into two groups: one receiving only chemotherapy and the other receiving both Botensilimab and chemotherapy.See study design
What are the potential side effects?
Botensilimab may cause immune-related side effects such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, digestive issues like diarrhea or nausea, skin rash, hormonal gland problems which could affect hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My diagnosis is pancreatic cancer confirmed by tissue analysis.
Select...
I am fully active or can carry out light work.
Select...
My nerve damage symptoms are mild or non-existent.
Select...
I agree to use effective birth control during the study.
Select...
My cancer has worsened despite FOLFIRINOX treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival
Secondary outcome measures
Change From Baseline In Carbohydrate Antigen 19-9
Complete Response
Duration Of Response
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: CombinationExperimental Treatment3 Interventions
Participants will receive botensilimab in combination standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Group II: Part 1: Combination (Safety Lead-in Phase)Experimental Treatment3 Interventions
Participants will receive botensilimab in combination with standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Group III: Part 2: Standard of CareActive Control2 Interventions
Participants will receive standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

Agenus Inc.Lead Sponsor
50 Previous Clinical Trials
4,945 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,770 Previous Clinical Trials
8,062,183 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05630183 — Phase 2
Pancreatic Cancer Research Study Groups: Part 1: Combination (Safety Lead-in Phase), Part 2: Combination, Part 2: Standard of Care
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT05630183 — Phase 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630183 — Phase 2

Frequently Asked Questions

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

Is the research currently recruiting participants?

"Indeed, per clinicaltrials.gov this experiment is actively searching for participants to take part in the study which was published on December 1st 2022 and went through its latest update on December 22nd of that year."

Answered by AI

In what geographic areas is this clinical trial currently being conducted?

"This trial has 14 potential sites for enrollment, including the USC Norris Comprehensive Cancer Center in Los Angeles and Georgetown Lombardi Comprehensive Cancer Center in Washington. Additionally, The Centre for Cancer and Blood Disorders in Bethesda is one of many other locations offering participation."

Answered by AI

Has Part 1: Combination (Safety Lead-in Phase) been given the required authorization by the FDA?

"Our assessment of Part 1: Combination (Safety Lead-in Phase) safety rating is a 2, denoting that there are some data available to affirm its security profile but no efficacy documentation yet."

Answered by AI

How many individuals have been inducted into this trial so far?

"Affirmative. According to information on clinicaltrials.gov, this medical study is still enrolling patients, having been originally posted on December 1st 2022 and updated most recently on the 22nd of that month. A total of 78 participants are being sought from 14 sites in order for it to be successful."

Answered by AI
~31 spots leftby Dec 2024