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PD-1 Inhibitor
Combination Therapy for Pancreatic Cancer
Phase 2
Recruiting
Led By Gulam Manji, MD,PhD
Research Sponsored by Gulam Manji
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with endocrine or acinar pancreatic carcinoma are not eligible for the study.
Patients with endocrine or acinar pancreatic carcinoma not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new combination of chemotherapy drugs and immunotherapy to see if it's effective in treating pancreatic cancer.
Who is the study for?
Adults over 18 with stage IV pancreatic adenocarcinoma, not endocrine or acinar types, who haven't had recent major surgery or cancer treatments. They must have a good performance status and organ function, no severe allergies to study drugs, and agree to use birth control if applicable.Check my eligibility
What is being tested?
The trial tests a combination of chemotherapy (gemcitabine and nab-paclitaxel), immunotherapy (cemiplimab), and a chemokine inhibitor (motixafortide) for effectiveness in shrinking tumors, extending life, and safety in metastatic pancreatic cancer patients.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells leading to inflammation in organs, infusion-related reactions from the drug entering the body, fatigue, blood disorders like low counts of different cell types which can increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is not endocrine or acinar pancreatic carcinoma.
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I do not have endocrine or acinar pancreatic cancer.
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I have been tested for blood clots and am receiving treatment if any were found.
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My pancreatic cancer diagnosis has been confirmed by a biopsy.
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I am fully active or can carry out light work.
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My cancer is confirmed as metastatic pancreatic adenocarcinoma.
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My stage IV cancer is confirmed by a biopsy and cannot be surgically removed.
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My pancreatic cancer diagnosis has been confirmed by a pathologist.
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I am 18 years old or older.
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My white blood cell count is healthy without needing medication.
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My biopsy confirms I have stage IV cancer that cannot be surgically removed.
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I am fully active or can carry out light work.
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My kidney function, measured by creatinine levels or CrCl, is within the normal range.
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My cancer can be measured and biopsied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (Complete Response (CR) + Partial Response (PR))
Secondary outcome measures
Disease Control Rate
Duration of Clinical Benefit
Incidence of Treatment Related Toxicities
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Motixafortide, Cemiplimab, Gemcitabine, Nab-PaclitaxelExperimental Treatment4 Interventions
Participants will receive standard FDA-approved doses of gemcitabine and nab-paclitaxel for pancreas cancer and cemiplimab at the dose that is approved for participants with skin cancer. Participants will also receive motixafortide at a dose that has been deemed safe in previous studies when used in combination with immunotherapy and chemotherapy. If the combination study treatment causes a serious side effect in participants, the study treatment will be modified.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Gemcitabine
2017
Completed Phase 3
~2070
Nab paclitaxel
2014
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Gulam ManjiLead Sponsor
4 Previous Clinical Trials
153 Total Patients Enrolled
3 Trials studying Adenocarcinoma
110 Patients Enrolled for Adenocarcinoma
Regeneron PharmaceuticalsIndustry Sponsor
617 Previous Clinical Trials
380,195 Total Patients Enrolled
1 Trials studying Adenocarcinoma
98 Patients Enrolled for Adenocarcinoma
BioLine RxUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have skin conditions like eczema or psoriasis but only on my skin.My cancer is not endocrine or acinar pancreatic carcinoma.My liver tests are normal or slightly elevated due to a blockage that can be treated.I have had surgery for pancreatic cancer.I do not have endocrine or acinar pancreatic cancer.I have been tested for blood clots and am receiving treatment if any were found.My heart's pumping ability is below normal or less than 50%.I have never had lung conditions like pulmonary fibrosis or pneumonitis, except for radiation-related issues.Men who are able to father a child must agree to use birth control.My pancreatic cancer diagnosis has been confirmed by a biopsy.My blood thinner medication has been stable for 2 weeks, and the study lead agrees it's okay despite my high clot risk.I have been hospitalized for severe depression or attempted suicide in the last two years.My side effects from cancer treatment are mild, except for hair loss and some nerve pain.I do not have uncontrolled skin, muscle, nerve disorders or a rare blood disorder.I have fluid buildup needing frequent drainage.I haven't had major surgery or significant injury in the last 2 weeks.I haven't had a severe infection needing antibiotics in the last 2 weeks, except for a treated bile duct infection.I haven't had a live vaccine in the last 4 weeks and don't plan to during or within 5 months after my treatment.I am fully active or can carry out light work.My cancer is confirmed as metastatic pancreatic adenocarcinoma.My stage IV cancer is confirmed by a biopsy and cannot be surgically removed.The researcher thinks that you have a medical condition that makes it unsafe for you to participate in the study.I am not on cancer treatment, except for hormone therapy.You are currently taking experimental drugs for other medical studies.I have had a stem cell or organ transplant before.I haven't had any cancer except for low-risk types in the past two years.I have stable thyroid issues or controlled Type 1 diabetes, but no other immune conditions.I had radiation therapy for pancreatic cancer less than 2 weeks ago.I have had cancer spread to my brain or its coverings.I have high calcium levels that aren't managed without ongoing treatment.I have or had hepatitis B.I have a significant liver condition.I have active tuberculosis.I haven't had major heart issues, seizures, uncontrolled high blood pressure, or unstable heart rhythm recently.I have not had severe bleeding in the last 28 days.My pancreatic cancer diagnosis has been confirmed by a pathologist.My blood clotting tests are within normal limits, or I've been on stable blood thinners for 2 weeks.I have had treatment for pancreatic cancer before.I haven't had immunosuppressive treatment in the last 2 weeks, except for a one-time approved dose.I have not received any blood transfusions in the last 4 weeks.I have been taking more than 10 mg of prednisone daily for over five days within the last month.I am 18 years old or older.My white blood cell count is healthy without needing medication.My biopsy confirms I have stage IV cancer that cannot be surgically removed.I am fully active or can carry out light work.My recent blood and organ function tests are within normal ranges.My bilirubin levels are within the normal range, or slightly higher if I have Gilbert's disease or a blockage that can be treated.My kidney function, measured by creatinine levels or CrCl, is within the normal range.My cancer can be measured and biopsied.I have cancer pain not controlled without changing pain meds in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is this study seeking to recruit?
"Affirmative. The information on clinicaltrials.gov elucidates that this investigation is currently soliciting participants. This research effort, which was initially published on November 9th 2020, needs 10 patients from 2 different medical centres to complete the trial."
Answered by AI
Has Motixafortide been evaluated in other investigations?
"Currently, there are 1169 investigations into Motixafortide which have been initiated. Of these ongoing trials, 325 reside in their third and final phase of development. Although the majority of research is based out of Shanghai, 61006 sites support studies for this medication worldwide."
Answered by AI
What medicinal applications is Motixafortide employed for?
"Motixafortide can be employed to treat those with a previous history of anthracycline-based therapies, metastatic cutaneous squamous cell carcinoma, and cancerous metastases."
Answered by AI
Could you please elucidate the risks of Motixafortide usage?
"Our team at Power assigned Motixafortide a rating of 2 as it is currently in Phase 2 clinical trials, with some safety data gathered but none indicating its efficacy."
Answered by AI
Are volunteers being enlisted for this experiment?
"Yes, the information available on clinicaltrials.gov reveals that this research effort is in search of participants. The trial was first made visible to the public on November 9th 2020 and has since been updated as recently as November 7th 2022; it requires 10 volunteers from 2 different medical centres."
Answered by AI
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