galinpepimut-S for Colorectal Carcinoma
Phase-Based Progress Estimates
Effectiveness
Safety
Colorectal Carcinoma+8 More
galinpepimut-S - BiologicalEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
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
- Colorectal Carcinoma
- Leukemia, Myelocytic, Acute
- Ovarian Cancer
- Triple-negative Breast Cancer
- Small-cell Lung Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 5 Secondary · Reporting Duration: First 9 weeks up to 32 months
Month 32
Immune Response (IR) to WT1 peptides within the vaccine mixture - Galinpepimut-S Pharmacodynamics - Exploratory endpoint - for all tumor types
PD Ligand 1 (PDL-1) expression in bone marrow biopsy samples - Pembrolizumab Pharmacodynamics - Exploratory Exploratory endpoint - for AML arm only
PD Ligand 1 (PDL-1) expression in malignant tissue biopsy samples - Pembrolizumab Pharmacodynamics - Exploratory Exploratory endpoint - for solid tumor arms
Month 32
Complete Response (CR) rate - for AML arm only
Duration of CR - for AML arm only
Duration of Response (DOR) - for solid tumor arms
Measurable Residual Disease (MRD) negativity rate - for AML arm only - Exploratory endpoint
Number and frequency of TRAEs, including UARs, and SAEs (safety parameters) - for all tumor types
Heart rate
Overall response rate (ORR) by iRECIST - for solid tumor arms
Time to next treatment (TNT) - for all tumor types
Time to response (TTR) - for all tumor types
Up to 32 months
Overall survival (OS) - Exploratory endpoint - for all tumor types
Progression-free survival (PFS) - Exploratory endpoint - for AML arm only
Progression-free survival (PFS) - Exploratory endpoint - for solid tumor arms
Trial Safety
Safety Progress
Side Effects for
Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
Trial Design
5 Treatment Groups
Colorectal Cancer (CRC)
1 of 5
Small Cell Lung Cancer (SCLC)
1 of 5
Triple Negative Breast Cancer (TNBC)
1 of 5
Acute Myelogenous Leukemia (AML)
1 of 5
Ovarian Cancer (OvC)
1 of 5
Experimental Treatment
90 Total Participants · 5 Treatment Groups
Primary Treatment: galinpepimut-S · No Placebo Group · Phase 1 & 2
Colorectal Cancer (CRC)Experimental Group · 2 Interventions: galinpepimut-S, Pembrolizumab · Intervention Types: Biological, Drug
Small Cell Lung Cancer (SCLC)Experimental Group · 2 Interventions: galinpepimut-S, Pembrolizumab · Intervention Types: Biological, Drug
Triple Negative Breast Cancer (TNBC)Experimental Group · 2 Interventions: galinpepimut-S, Pembrolizumab · Intervention Types: Biological, Drug
Acute Myelogenous Leukemia (AML)Experimental Group · 2 Interventions: galinpepimut-S, Pembrolizumab · Intervention Types: Biological, Drug
Ovarian Cancer (OvC)Experimental Group · 2 Interventions: galinpepimut-S, Pembrolizumab · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first 9 weeks up to 32 months
Who is running the clinical trial?
Sellas Life Sciences GroupLead Sponsor
7 Previous Clinical Trials
566 Total Patients Enrolled
Cancer Insight, LLCIndustry Sponsor
8 Previous Clinical Trials
464 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,653 Previous Clinical Trials
4,953,517 Total Patients Enrolled
Nicholas J Sarlis, MD, PhDStudy DirectorSELLAS Life Sciences Group, Inc.
1 Previous Clinical Trials
116 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:People with advanced or metastatic solid tumors that have continued to progress after treatment with available therapies, or who are intolerant to treatment, or refuse standard treatment, may be eligible for participation in this study
, was associated with a significantly improved OS
Having cytoreductive therapy with hydroxyurea or leukapheresis at the time of initial diagnosis, and then transitioning immediately to HMA therapy, was associated with a significantly improved OS.
who met all inclusion criteria
Patients who are male or female and are at least 18 years old on the day they sign the informed consent form are eligible for the study
Patients in both the solid tumor and AML arms of the study will have their initial primary tumor or recent biopsy of metastatic disease tested for WT1 expression via IHC
Some patients may have only received two or three lines of therapy for metastatic colorectal cancer, one or two lines for ovarian cancer, one line for small cell lung cancer, and one line for triple negative breast cancer
In order to be eligible for the solid tumor arms of the study, patients must have measurable disease based on RECIST v1.1 as determined by the local study team.
I can understand and agree to the terms of the study, and am able to sign the informed consent form.
Status
The person has been a frontline patient with HMAs since they were first diagnosed with AML.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Cancer Related
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