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Cancer Vaccine
galinpepimut-S for Acute Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by Sellas Life Sciences Group
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 first 9 weeks up to 32 months
Awards & highlights
Study Summary
This trial will test the safety and efficacy of a new cancer treatment combining galinpepimut-S with pembrolizumab. Up to 90 patients will be enrolled, and treatment will last for a maximum of 2.13 years.
Eligible Conditions
- Acute Myeloid Leukemia
- Colorectal Cancer
- Ovarian Cancer
- Breast Cancer
- Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first 9 weeks up to 32 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 9 weeks up to 32 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response (CR) rate - for AML arm only
Number and frequency of TRAEs, including UARs, and SAEs (safety parameters) - for all tumor types
Heart rate
Secondary outcome measures
Duration of CR - for AML arm only
Duration of Response (DOR) - for solid tumor arms
Overall response rate (ORR) by iRECIST - for solid tumor arms
+2 moreOther outcome measures
Immune Response (IR) to WT1 peptides within the vaccine mixture - Galinpepimut-S Pharmacodynamics - Exploratory endpoint - for all tumor types
Measurable Residual Disease (MRD) negativity rate - for AML arm only - Exploratory endpoint
Overall survival (OS) - Exploratory endpoint - for all tumor types
+4 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
5Treatment groups
Experimental Treatment
Group I: Triple Negative Breast Cancer (TNBC)Experimental Treatment2 Interventions
N=15;
TNBC priorly Rxed with 1 line of ChemoRx with residual or recurrent disease (2nd line); estrogen (ER) and progesterone receptor (PgR) negative, and HER2(-) by IHC AND HER2 non-amplified by fluorescence in situ hybridization; weak IHC positivity for ER or PgR (i.e., < 5%) eligible; must have undergone 2nd line therapy after 1st line Rx could include: neoadjuvant Rx if macroscopic disease still present after surgery OR adjuvant Rx but only if relapse occurred > 6 months from the start of pembrolizumab (P);
PFS and OS to be assessed in all;
GM-CSF before each galinpepimut-S (GPS) vaccine injection; first 2 GPS injections (monotherapy) Q3 wks, followed by GPS co-administered with pembrolizumab (P) Q3wks x 4. After that, there will be 1 unpaired administration of P, and GPS will be resumed Q3wks x 6. After a 12-wk interval where 3 unpaired administrations of P will occur, GPS will resume Q12wks x 4. After 84 wks, non-progressors will continue in the study on P alone.
Group II: Small Cell Lung Cancer (SCLC)Experimental Treatment2 Interventions
N=20;
Advanced SCLC priorly Rxed with 1 line of ChemoRx (2nd line); must have measurable disease by imaging after they progressed or were resistant to 1 prior systemic therapy; asymptomatic or treated brain metastases are allowed;
PFS and OS to be assessed in all;
GM-CSF before each galinpepimut-S (GPS) vaccine injection; first 2 GPS injections (monotherapy) Q3 wks, followed by GPS co-administered with pembrolizumab (P) Q3wks x 4. After that, there will be 1 unpaired administration of P, and GPS will be resumed Q3wks x 6. After a 12-wk interval where 3 unpaired administrations of P will occur, GPS will resume Q12wks x 4. After 84 wks, non-progressors will continue in the study on P alone.
Group III: Ovarian Cancer (OvC)Experimental Treatment2 Interventions
N=20;
Metastatic OvC priorly Rxed with ≥1 line of platinum-containing ChemoRx (2nd/3rd line) with either relapse or disease refractoriness; interval surgery permitted, as long as subjects have measurable disease by imaging and concomitant CA-125 increase, and/or biopsy showing OvC; must have either received (or been offered) bevacizumab therapy; those with BRCA germline mutations (gBRCA mut) must have been offered therapy with poly-ADP ribose polymerase (PARP) inhibitors.
PFS and OS to be assessed in all;
GM-CSF before each galinpepimut-S (GPS) vaccine injection; first 2 GPS injections (monotherapy) Q3 wks, followed by GPS co-administered with pembrolizumab (P) Q3wks x 4. After that, there will be 1 unpaired administration of P, and GPS will be resumed Q3wks x 6. After a 12-wk interval where 3 unpaired administrations of P will occur, GPS will resume Q12wks x 4. After 84 wks, non-progressors will continue in the study on P alone.
Group IV: Colorectal Cancer (CRC)Experimental Treatment2 Interventions
N=20;
Metastatic CRC priorly Rxed with ≥2 lines of ChemoRx (3rd/4th line); must have documented disease progression post last administration of or intolerance to standard therapies, which must have included a fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and, if KRAS wild-type, cetuximab or panitumumab. Prior regorafenib or trifluridine/tipiracil is allowed, but not mandated;
PFS and OS to be assessed in all;
GM-CSF before each galinpepimut-S (GPS) vaccine injection; first 2 GPS injections (monotherapy) Q3 wks, followed by GPS co-administered with pembrolizumab (P) Q3wks x 4. After that, there will be 1 unpaired administration of P, and GPS will be resumed Q3wks x 6. After a 12-wk interval where 3 unpaired administrations of P will occur, GPS will resume Q12wks x 4. After 84 wks, non-progressors will continue in the study on P alone.
Group V: Acute Myelogenous Leukemia (AML)Experimental Treatment2 Interventions
N=15;
Pts with AML who are not eligible for allogeneic stem cell transplant and have been able to achieve morphological partial remission (PR) as their best ever response at the time of completion of their 4th cycle of upfront Rx with HMA; prior initial upfront hydroxyurea or leukapheresis Rx or history of induction early failure after up to 2 cycles of ChemoRx ("7+3" or similar regimen) with seamless immediate transitioning to HMA Rx eligible; must remain on HMA therapy throughout the trial.
PFS and OS to be assessed in all;
GM-CSF before each galinpepimut-S (GPS) vaccine injection; first 2 GPS injections (monotherapy) Q3 wks, followed by GPS co-administered with pembrolizumab (P) Q3wks x 4. After that, there will be 1 unpaired administration of P, and GPS will be resumed Q3wks x 6. After a 12-wk interval where 3 unpaired administrations of P will occur, GPS will resume Q12wks x 4. After 84 wks, non-progressors will continue in the study on P alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Sellas Life Sciences GroupLead Sponsor
8 Previous Clinical Trials
713 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,539 Total Patients Enrolled
Cancer Insight, LLCIndustry Sponsor
9 Previous Clinical Trials
490 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What does this medical experiment seek to accomplish?
"This medical study seeks to measure its efficacy over the course of 9 weeks and up to 32 months, with a focus on Complete Response (CR) rate for AML patients. Secondary objectives include Time to Next Treatment (TNT), Duration of CR for AML arm only, and Time to Response (TTR)."
Answered by AI
At what number of healthcare sites is this experiment taking place?
"Memorial Cancer Institute in Hollywood, Florida; Oncology Hematology Care, Inc. in Cincinnati, Ohio; and Miami Cancer Institute at Baptist Health, Inc. in Miami, California are three of the 15 recruitment sites for this clinical trial."
Answered by AI
What is the common purpose of administering galinpepimut-S?
"Galinpepimut-S is typically employed to treat malignant tumors, however it can also prove effective in cases of unresectable melanoma, microsatellite instability high and when chemotherapy has failed."
Answered by AI
Are there still openings to participate in this experiment?
"At this point in time, the clinical trial is not actively enrolling. Initially published on June 28th 2019 and most recently adjusted February 18th 2022, it does not currently seek participants. However, if you are seeking a study to join there are 2,346 colorectal carcinoma related trials looking for candidates as well as 961 galinpepimut-S studies accepting enrolment."
Answered by AI
Have additional investigations been conducted involving galinpepimut-S?
"Galinpepimut-S was initially assessed in 2010 at City of Hope. Consequently, there have been 251 finished trials and as of now 961 studies are actively enrolling patients with many occurring out of Hollywood, Florida."
Answered by AI
What is the current enrollment rate for this research endeavor?
"Unfortunately, this research project is not currently recruiting. It was posted on June 28th 2019 and last updated on February 18th 2022. Alternately, 2346 trials are open to participants with colorectal carcinoma while 961 studies are admitting test subjects for galinpepimut-S treatments."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Father has lung cancer.
PatientReceived no prior treatments
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