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Cancer Vaccine
Combination Immunotherapy for Prostate Cancer
Phase 2
Waitlist Available
Led By Ravi A Madan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, one year
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a combination of three drugs as a possible treatment for people with prostate cancer.
Who is the study for?
Men aged 18+ with specific prostate cancer types, who've had a rise in PSA after treatments like surgery or radiation. They must agree to use effective contraception and have no other active cancers or life-threatening illnesses. Participants should not have received certain therapies recently and must be willing to travel for follow-up visits.
What is being tested?
The trial tests if the combination of PROSTVAC, CV301, and MSB0011359C (M7824) can trigger an anti-tumor response in patients with biochemically recurrent prostate cancer. Patients will receive these drugs over at least 7 months and undergo regular monitoring including blood tests, scans, and physical exams.
What are the potential side effects?
Potential side effects may include typical reactions from immunotherapy such as flu-like symptoms, injection site reactions, fatigue, possible autoimmune responses where the body attacks its own cells, allergic reactions to components of the vaccines used in treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Immunotherapy
Secondary study objectives
fraction of subjects with grade 3 and grade 4 adverse events
slope of the PSA change over time
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: 3/combination vaccine therapy +/- surveillanceExperimental Treatment3 Interventions
Surveillance as needed followed by Prostvac + CV301
Group II: 2/combination therapy + surveillance (closed)Experimental Treatment4 Interventions
Surveillance followed by Prostvac + CV301 then Prostvac + CV301 + MSB0011359C
Group III: 1/combination therapy (closed December 2018)Experimental Treatment4 Interventions
Prostvac + CV301+ MSB0011359C
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PROSTVAC-F
2018
Completed Phase 3
~1490
CV301
2016
Completed Phase 2
~100
PROSTVAC-V
2018
Completed Phase 3
~1390
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,907 Previous Clinical Trials
41,012,020 Total Patients Enrolled
515 Trials studying Prostate Cancer
332,848 Patients Enrolled for Prostate Cancer
Ravi A Madan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
17 Previous Clinical Trials
1,119 Total Patients Enrolled
9 Trials studying Prostate Cancer
806 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking medications like finasteride or saw palmetto that affect PSA levels.You are allergic to eggs or certain antibiotics like gentamicin or tobramycin.I am HIV positive.I haven't taken daily steroids for more than 2 weeks in the last month.I have had my spleen removed.Your immune system is weakened due to:I have an active autoimmune disease like lupus or thyroiditis.I have an autoimmune disease that hasn't needed strong medication or endangered my organs.I have a condition that weakens my immune system.I have not had an organ transplant that requires immunosuppression.I have had a severe allergic reaction to monoclonal antibodies.You had allergic reactions in the past to vaccines that are similar to the poxviral vaccine (like the vaccinia vaccine).I have not had major surgery in the last 4 weeks.I have a history of skin conditions like eczema.I have had chemotherapy before for my condition.I am fully active or can carry out light work.I have not had a recent serious heart or stroke issue.I have not received a blood transfusion in the last 2 weeks.I am willing to accept blood products if needed.I am mostly self-sufficient and can carry out daily activities.I have recovered from the side effects of my last cancer treatment.I haven't had any other cancers except for non-dangerous skin cancer or bladder cancer in the last 3 years.I agree to use effective contraception during and for four months after the study.My liver is functioning well enough for treatment.My PSA levels are rising after prostate surgery, currently above 0.8 ng/mL.I agree to continue hormone therapy for my cancer.This study is specifically looking for participants who have experienced a recurrence of their disease based on certain biochemical markers.I haven't had immunotherapy in the last 3 years, except as part of a specific group in a study.My PSA levels have been rising over time, following specific treatment guidelines.My kidneys are working well, with a creatinine clearance over 50 mL/min.I have a tumor in my liver or chest that is 10 cm or larger.My PSA levels have increased by 2 ng/mL or more after radiation therapy.My prostate cancer has spread to my bones or lymph nodes.My PSA levels have been increasing over the last month.I am 18 years old or older.My cancer is getting worse despite low testosterone levels.You have had serious side effects from a smallpox vaccine in the past.
Research Study Groups:
This trial has the following groups:- Group 1: 1/combination therapy (closed December 2018)
- Group 2: 2/combination therapy + surveillance (closed)
- Group 3: 3/combination vaccine therapy +/- surveillance
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.
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