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Cancer Vaccine
Personalized Cancer Vaccine + Pembrolizumab for Lymphocytic Leukemia
Phase 1
Recruiting
Led By Inhye Ahn, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient's CLL must have an unmutated immunoglobulin heavy chain variable (IGHV) region gene, defined as < 2% mutated compared to germline
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is studying a personalized vaccine made from a person's own tumor to see if it can help treat patients with CLL.
Who is the study for?
This trial is for adults over 18 with untreated chronic lymphocytic leukemia (CLL) that has an unmutated IGHV gene and no history of CLL-directed therapy. Participants must not expect to need treatment within six months, have measurable disease, normal organ/marrow function, and agree to use effective contraception or abstain from sexual activity. Excluded are those with prior CLL therapies, autoimmune diseases, large lymph nodes, certain genetic mutations in CLL cells, rapid disease progression, low immunoglobulin levels or active infections.Check my eligibility
What is being tested?
The study tests a personalized Neoantigen Vaccine (NeoVax) combined with Poly-ICLC and Cyclophosphamide against Pembrolizumab for treating CLL. The vaccine aims to stimulate the patient's immune system specifically against their cancer cells by using unique markers found on their tumor.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site for the vaccine; flu-like symptoms such as fever and chills; fatigue; possible organ inflammation due to Pembrolizumab; allergic reactions; blood count changes leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My CLL has a specific genetic feature with less than 2% mutation.
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I am 18 years old or older.
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I have been diagnosed with CLL according to the 2018 guidelines.
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I am fully active or can carry out light work.
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My liver functions and blood cell counts are within normal ranges.
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I am a woman not in menopause for over 2 years, without a hysterectomy or sterilization, and will use birth control.
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At least 7 vaccines can be made for my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of neoantigen identification
Feasibility of vaccine generation
Safety of NeoVax
Trial Design
3Treatment groups
Experimental Treatment
Group I: Neovax + Low-dose cyclophosphamide + PembrolizumabExperimental Treatment3 Interventions
NeoVax will be administered in a priming and booster phase.
The priming shots will comprise days 1, 4, 8, 15, and 22.
Booster shots will be given on days 78 and 134.
Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5
Pembrolizumab will be administered starting on Week 12 Day 78 and for up to 17 cycles (approximately 1 year).
Group II: Neovax + Low-dose cyclophosphamideExperimental Treatment2 Interventions
NeoVax will be administered in a priming and booster phase.
The priming shots will comprise days 1, 4, 8, 15, and 22.
Booster shots will be given on days 78 and 134.
Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5
Group III: NeoVaxExperimental Treatment1 Intervention
NeoVax will be administered in a priming and booster phase.
The priming shots will comprise days 1, 4, 8, 15, and 22.
Booster shots will be given on days 78 and 134.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
BioNTech SEIndustry Sponsor
64 Previous Clinical Trials
107,666 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,989 Total Patients Enrolled
Oncovir, Inc.Industry Sponsor
23 Previous Clinical Trials
633 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV-positive and on combination antiretroviral therapy.My CLL has a specific genetic feature with less than 2% mutation.I have had at least two blood tests for lymphocytes since my CLL diagnosis.I have been diagnosed with CLL according to the 2018 guidelines.I am fully active or can carry out light work.My liver functions and blood cell counts are within normal ranges.I agree to provide blood and saliva samples for genetic testing.I have received treatment for CLL within the last 2 years.I am not on long-term steroids or drugs that affect my immune system.I haven't had vaccines for infectious diseases within 2 weeks before getting NeoVax.I am 18 years old or older.I do not have an active autoimmune disease or conditions that weaken my immune system, with some exceptions.I have an autoimmune condition that affects my blood cells and it's not under control.My lymph nodes are not larger than 5 cm according to a CT scan.My CLL cells show a specific genetic change in more than 10% of cells.My immune system is weak, shown by low immunoglobulin levels or I need regular IVIG treatments.I have a chronic infection with HIV, hepatitis B, or C.I am a woman not in menopause for over 2 years, without a hysterectomy or sterilization, and will use birth control.At least 7 vaccines can be made for my treatment.I do not have any unmanaged ongoing illnesses.My CLL has transformed into a more aggressive form.I have CLL but haven't needed treatment for it and likely won't need any for the next 6 months.I have had a bone marrow or stem cell transplant.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.My cancer has spread to my brain or spinal cord.I have had cancer before, but it's one of the exceptions allowed.
Research Study Groups:
This trial has the following groups:- Group 1: Neovax + Low-dose cyclophosphamide + Pembrolizumab
- Group 2: NeoVax
- Group 3: Neovax + Low-dose cyclophosphamide
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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
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.
What other research has been done on Pembrolizumab?
"At present, 1748 clinical trials are ongoing for the evaluation of Pembrolizumab. Of those studies, 274 have reached Phase 3. The vast majority of these investigations are centered in Philadelphia, Pennsylvania though there are 62845 sites running tests worldwide."
Answered by AI
Are there any vacancies remaining for participants in this experiment?
"Affirmative, according to clinicaltrials.gov this research project is currently seeking volunteers. Initially posted on August 18th 2021 and recently updated on September 26th 2022, the trial requires 15 participants across two sites."
Answered by AI
Could you please provide the aggregate number of participants in this investigation?
"Affirmative. According to clinicaltrials.gov, this research trial, which was initially posted on August 18th 2021, is currently recruiting participants. A total of 15 people must be enrolled from 2 distinct sites."
Answered by AI
To what extent does Pembrolizumab present a health risk to participants?
"Due to the limited clinical data collected on Pembrolizumab, our team at Power has rated its safety as a 1. This is because this trial is still in Phase 1 stages and thus there are few studies confirming both efficacy and safety."
Answered by AI
What ailments can be addressed using Pembrolizumab?
"Pembrolizumab is commonly prescribed to combat malignant melanoma of the skin, as well as recurrent cervical cancer, leukemia, refractory and relapsed mediastinal large b-cell lymphoma."
Answered by AI
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