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Cancer Vaccine
Cancer Vaccine + GM-CSF/Pembrolizumab for Advanced Stage Adenocarcinoma
Phase 1 & 2
Recruiting
Research Sponsored by Tianhong Li
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with advanced/metastatic or recurrent solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 are eligible for participation
Subjects of at least 18 years of age with histologically confirmed diagnosis of adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after the last dose of study treatment
Awards & highlights
Study Summary
This trial is testing the safety of a cancer vaccine & it's side effects in treating adenocarcinoma. The vaccine is designed to target a protein called labyrinthine, which is found on the surface of tumor cells. If successful, this study may improve the general knowledge about the vaccine & how the body may generate an immune response to kill tumor cells.
Who is the study for?
Adults with advanced or recurrent adenocarcinoma, who have measurable disease and a positive immune response to common antigens. They must be in good physical condition (ECOG 0-1), not pregnant, agree to contraception, and have no untreated brain metastases or severe autoimmune diseases. Prior treatments should be completed at least 2-3 weeks before the vaccine.Check my eligibility
What is being tested?
The trial is testing Labvax 3(22)-23 cancer vaccine with GM-CSF alone or combined with pembrolizumab for advanced adenocarcinoma. The vaccine targets labyrinthin on tumor cells to stimulate an immune response, potentially enhanced by GM-CSF and pembrolizumab.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms from the vaccine and GM-CSF, fatigue, skin rash, digestive issues from pembrolizumab; also potential for more serious immune-related adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread or returned, and its size can be measured.
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I am 18 or older with a confirmed diagnosis of adenocarcinoma.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am eligible for pembrolizumab treatment.
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I am a man who can father children and will use birth control during and after the study as required.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after the last labvax 3(22)-23 vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after the last labvax 3(22)-23 vaccination
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Dose-limiting toxicities (DLT)
Phase 2: Objective response rate (ORR)
Secondary outcome measures
Phase 1: Objective response rate (ORR)
Phase 2: Adverse events (AEs)
Phase 2: Dose-limiting toxicities (DLT)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2 Treatment (sargramostim, LabVax 3(22)-23, pembrolizumab)Experimental Treatment3 Interventions
Pembrolizumab will be given intravenously every 3 weeks for up to 12 cycles on Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, and 34. Participants will be given LabVax 3(22)-23 (intradermally) and adjuvant GM-CSF (subcutaneously) on weeks 7, 8, 10, 14, and 18.
Group II: Phase 1 Treatment (sargramostim, LabVax 3(22)-23)Experimental Treatment2 Interventions
Patients receive sargramostim SC and LabVax 3(22)-23 ID on weeks 1, 2, 4, 8, and 12 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Sargramostim
2008
Completed Phase 4
~850
Find a Location
Who is running the clinical trial?
Tianhong LiLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,692 Previous Clinical Trials
40,929,929 Total Patients Enrolled
432 Trials studying Adenocarcinoma
79,362 Patients Enrolled for Adenocarcinoma
LabyRx Immunologic TherapeuticsUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with anti-PD-1 or anti-PD-L1 therapy for lung cancer.I've had cancer treatment but either didn't respond or couldn't tolerate it, and I've mostly recovered from side effects.I don't have untreated brain metastases and if treated, I've been stable and off steroids for a week.I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.I haven't had cancer treatment with monoclonal antibodies in the last 3 weeks or have recovered from their side effects.My cancer has spread or returned, and its size can be measured.I have completed all previous cancer treatments at least 3 weeks ago, and any radiation at least 2 weeks ago.I take immunosuppressants for an autoimmune disease, but not more than 10 mg of prednisone or its equivalent daily.My organs are functioning well.My cancer has worsened after treatment for a specific mutation.I am 18 or older with a confirmed diagnosis of adenocarcinoma.I have not received a live vaccine in the last 30 days.I am fully active or restricted in physically strenuous activity but can do light work.I have an active tuberculosis infection.I have not had my spleen removed.I am currently being treated for an infection.I have not taken high-dose steroids or immunosuppressants in the last week.I am not allergic to GM-CSF, yeast products, or have high leukemic blasts.I am eligible for pembrolizumab treatment.I have had severe lung inflammation from past cancer treatments.My lung cancer is confirmed to be a specific type called labyrinthin-positive adenocarcinoma.I don't have any health issues that would stop me from following the study's procedures.I agree to use birth control during and up to 120 days after the study.I am a man who can father children and will use birth control during and after the study as required.I don't have untreated brain metastases or symptoms from them.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 Treatment (sargramostim, LabVax 3(22)-23, pembrolizumab)
- Group 2: Phase 1 Treatment (sargramostim, LabVax 3(22)-23)
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.
Has Sargramostim been granted approval by the Food and Drug Administration?
"Due to limited data on safety and efficiency, our team at Power assigned Sargramostim a score of 1 when assessing its risk profile."
Answered by AI
How many participants are actively engaged in this medical study?
"Affirmative, the details posted on clinicaltrials.gov show that this research project is currently recruiting participants. The trial was initially uploaded to the website on October 13th 2021 and updated for a second time on October 29th 2021. At present, 10 volunteers are sought from one specific location."
Answered by AI
Is this research team currently seeking participants?
"As per clinicaltrials.gov, this investigation is actively seeking participants; it was initiated on October 13th 2021 and modified lastly on October 29th 2021."
Answered by AI
What other research projects have been conducted on Sargramostim?
"Currently, 43 clinical trials are exploring the efficacy of Sargramostim with 5 studies in their final stages. Although many of these tests are located within Seattle, Washington's boundaries, there exists a total 1888 sites researching this medication throughout America."
Answered by AI
Who else is applying?
What site did they apply to?
University of California Davis Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I would like to avoid life altering surgery if at all possible.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- University of California Davis Comprehensive Cancer Center: < 24 hours
Average response time
- < 1 Day
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