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Taxane
Nab-Paclitaxel + Nivolumab for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Douglas R Adkins, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine <1.5 x IULN or creatinine clearance > 50 mL/min by Cockcroft-Gault
Measurable disease per RECIST. Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 13 months)
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat pancreatic cancer. The hypothesis is that the new combination will work better than the standard of care.
Who is the study for?
Adults with recurrent or metastatic head and neck squamous-cell carcinoma that worsened after PD-1/PD-L1 inhibitor therapy. They must be in good physical condition, have normal organ and bone marrow function, not be pregnant or breastfeeding, agree to use contraception, and have no history of severe allergies to similar drugs or serious autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining nab-paclitaxel with nivolumab against this type of cancer. The goal is to see if this combination improves response rates and progression-free survival compared to past results from other treatments.See study design
What are the potential side effects?
Possible side effects include allergic reactions related to the drug components, potential harm to a developing fetus (hence the need for contraception), increased risk of infection due to immune system effects, nerve damage (neuropathy), fatigue, digestive issues, and blood cell count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the normal range.
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My cancer can be measured by scans or physical exam.
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I know my p16 status for my neck or oropharynx cancer.
Select...
My cancer is in the mouth, throat, or neck and has come back or spread.
Select...
My cancer can be measured by scans or physical exam.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I know my p16 status for my neck or oropharynx cancer.
Select...
I am 18 years old or older.
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My blood counts and liver/kidney functions are within normal ranges.
Select...
I am 18 years old or older.
Select...
My cancer is in the mouth, throat, or neck and has been confirmed by a lab test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 13 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 13 months)
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) as assessed by RECIST 1.1
Secondary outcome measures
Duration of response (DOR)
Incidence of adverse events
Incidence of immune-related adverse events
+8 moreSide effects data
From 2017 Phase 4 trial • 143 Patients • NCT0215114968%
Fatigue
66%
Anaemia
59%
Peripheral sensory neuropathy
51%
Neutropenia
47%
Nausea
44%
Thrombocytopenia
43%
Diarrhoea
40%
Alopecia
37%
Constipation
32%
Decreased appetite
24%
Cough
24%
Epistaxis
24%
Dyspnoea
24%
Dehydration
21%
Stomatitis
21%
Leukopenia
21%
Neutrophil count decreased
21%
Dizziness
19%
Vomiting
18%
Oedema peripheral
16%
Hyponatraemia
15%
Hypokalaemia
13%
Abdominal pain
13%
Platelet count decreased
13%
Weight decreased
12%
Hypomagnesaemia
12%
Back pain
12%
Rash maculo-papular
12%
Insomnia
10%
Headache
10%
Urinary tract infection
10%
Hyperglycaemia
10%
Pain in extremity
10%
Asthenia
10%
Dysgeusia
10%
Peripheral motor neuropathy
9%
Upper respiratory tract infection
9%
Overdose
9%
Pain
9%
Dry skin
7%
Haemoptysis
7%
Muscular weakness
7%
Musculoskeletal chest pain
7%
White blood cell count decreased
7%
Gastrooesophageal reflux disease
7%
Pyrexia
7%
Fall
7%
Arthralgia
6%
Hypocalcaemia
6%
Dysphagia
6%
Oral candidiasis
6%
Contusion
6%
Oropharyngeal pain
6%
Pneumonia
6%
Hypotension
4%
Non-cardiac chest pain
4%
Vision blurred
3%
Syncope
3%
Anxiety
3%
Febrile neutropenia
3%
Pulmonary embolism
1%
Hypertension
1%
Sepsis
1%
Hyperbilirubinaemia
1%
Gallbladder obstruction
1%
Diarrhoea infectious
1%
Gastrointestinal haemorrhage
1%
Generalised oedema
1%
Atrial tachycardia
1%
Sinus tachycardia
1%
Deep vein thrombosis
1%
Odynophagia
1%
Serratia infection
1%
Renal failure
1%
Chills
1%
Dysphonia
1%
Acute myocardial infarction
1%
Atrial fibrillation
1%
Femur fracture
1%
Clostridium difficile colitis
1%
Aspartate aminotransferase increased
1%
Femoral neck fracture
1%
Oesophageal candidiasis
1%
Alanine aminotransferase increased
1%
Hypoglycaemia
1%
Blood alkaline phosphatase increased
1%
Pneumonitis
1%
Orthostatic hypotension
1%
Blood creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)
Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)
Trial Design
1Treatment groups
Experimental Treatment
Group I: nab-Paclitaxel + NivolumabExperimental Treatment2 Interventions
nab-Paclitaxel 125 mg/m^2 intravenous (IV) on days 1, 8 & 15 of each 28-day cycle.
Nivolumab 480 mg IV Day 1 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,930 Previous Clinical Trials
2,298,939 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,634 Previous Clinical Trials
4,126,809 Total Patients Enrolled
Douglas R Adkins, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
288 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had cancer before, but I finished treatment over a year ago and am now cancer-free.My kidney function is within the normal range.I have had an organ or stem cell transplant from a donor.My cancer can be measured by scans or physical exam.I know my p16 status for my neck or oropharynx cancer.I agree to use birth control during and for 6 months after the study if I can have children.My brain metastases are stable, not new or growing, and I've been on a steady dose of steroids.I agree to use birth control during and for 6 months after the study.I haven't taken high doses of steroids or had severe autoimmune issues with PD-1 treatments.I have an autoimmune disease but haven't needed strong medication for it in the last 6 months.My cancer's PD-L1 status may not be tested, but it's better if it is.I do not have any serious illnesses that are not under control.My cancer worsened while on PD-1 or PD-L1 inhibitor therapy, not as part of a cure attempt.My cancer is in the mouth, throat, or neck and has come back or spread.My cancer worsened while on PD-1 or PD-L1 inhibitors.My cancer can be measured by scans or physical exam.My platelet count is above 100,000 and I haven't had a transfusion in the last week.I am fully active and can carry on all my pre-disease activities without restriction.My bone marrow and organs are functioning normally.I know my p16 status for my neck or oropharynx cancer.I am 18 years old or older.I do not have severe numbness or pain in my hands or feet.My blood counts and liver/kidney functions are within normal ranges.My cancer has been or should be tested for PD-L1, but it's not mandatory for the trial.I am 18 years old or older.My cancer is in the mouth, throat, or neck and has been confirmed by a lab test.I have been treated with a taxane for recurrent or metastatic disease.I received taxane therapy for my cancer, and it came back within 6 months after finishing treatment.
Research Study Groups:
This trial has the following groups:- Group 1: nab-Paclitaxel + Nivolumab
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 is nab-paclitaxel used to treat patients?
"Nab-paclitaxel can be used in cases of unresectable melanoma, squamous cell carcinoma, and to prevent cancer recurrence."
Answered by AI
Has nab-paclitaxel been federally sanctioned for use?
"Nab-paclitaxel's safety is estimated to be a 2. This rating comes from the fact that this is only a Phase 2 trial, so while there are reports supporting its safety, there is no data yet backing up its efficacy."
Answered by AI
What is the total number of people that will be included in this research project?
"According to the latest information on clinicaltrials.gov, this research study is still recruiting patients. The trial was originally posted on September 28th, 2021 and has since been updated on November 16th, 2022. So far, 53 people have been recruited from 1 site."
Answered by AI
Are there any current vacancies for this research project?
"That is accurate. Information available on clinicaltrials.gov affirms that this trial, which was established on September 28th 2021, is still looking for participants. The study requires 53 patients and is being conducted at a single location."
Answered by AI
Are there other similar experiments involving nab-paclitaxel?
"At the moment, 1575 separate clinical trials are underway to assess nab-paclitaxel's efficacy. Out of those ongoing projects, 305 have advanced to Phase 3 testing. Most of these tests are taking place in Shanghai but there are 80258 total locations around the world where researchers are running experiments concerning nab-paclitaxel."
Answered by AI
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