Brief Summary

To evaluate the safety, tolerability, and anti-tumor activity of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Sep 2019

Typical duration for phase_1

Geographic Reach

1 country

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

First Submitted

Initial submission to the registry

November 28, 2018

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed

10 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2022

Completed

2.1 years until next milestone

Results Posted

Study results publicly available

November 19, 2024

Completed

Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

2.8 years

First QC Date

November 28, 2018

Results QC Date

March 7, 2024

Last Update Submit

November 12, 2024

Conditions

Acute Myelogenous Leukemia Ovarian Cancer Colorectal Cancer Triple-negative Breast Cancer Small-cell Lung Cancer

Keywords

peptide vaccineimmuno-oncologyWT1-expressing tumorsgalinpepimut-SpembrolizumabPD1 inhibitorcheckpoint inhibitorcombination immunotherapyheterocliticmultivalentoff-the-shelf vaccineHLA alleleWT1 vaccineSLS-001WT1 analog peptide vaccine

Outcome Measures

Primary Outcomes (2)

Overall Response Rate (ORR) - Best Overall Response
Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirements). Best overall response is defined as the best overall visit response in the following order: CR, PR, SD, PD, or UE as measured by RECIST 1.1
33 months
Overall Response Rate (ORR) - Overall Response Rate
Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirement). Overall response rate is defined as the proportion of participants with a best overall response of CR or PR as defined by RECIST 1.1
33 months

Other Outcomes (2)

Progression-free Survival (PFS) - Kaplan Meier Estimate
33 months
Overall Survival (OS) - Kaplan Meier Estimate
33 months

Study Arms (5)

Colorectal Cancer (CRC) - opened but since only one subject enrolled, not included for analyses

EXPERIMENTAL

* N=20 (planned); * Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Biological: galinpepimut-SBiological: pembrolizumabOther: MontanideBiological: GM-CSF

Ovarian Cancer (OvC)

EXPERIMENTAL

* N=20 (planned); * Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Biological: galinpepimut-SBiological: pembrolizumabOther: MontanideBiological: GM-CSF

Small Cell Lung Cancer (SCLC) - not opened

EXPERIMENTAL

* N=20 (planned); * Advanced SCLC previously treated with one line of prior systemic chemotherapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Biological: galinpepimut-SBiological: pembrolizumabOther: MontanideBiological: GM-CSF

Triple Negative Breast Cancer (TNBC) - not opened

EXPERIMENTAL

* N=15 (planned); * TNBC previously treated with one line of prior systemic chemotherapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Biological: galinpepimut-SBiological: pembrolizumabOther: MontanideBiological: GM-CSF

Acute Myelogenous Leukemia (AML) - not opened

EXPERIMENTAL

* N=15 (planned); * AML (any age) who are not eligible for allogeneic hematopoietic stem cell transplant and have been able to achieve partial response (PR) while receiving frontline therapy with hypomethylating agents (HMAs) * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Biological: galinpepimut-SBiological: pembrolizumabOther: MontanideBiological: GM-CSF

Interventions

galinpepimut-SBIOLOGICAL

* Induction phase: the first two GPS + Montanide injections are administered Q3W on Week 0 and Week 3. Thereafter, GPS + Montanide is co-administered with pembrolizumab Q3W (Weeks 6, 9, 12, 15, 18). * Early immune booster phase: A single administration of pembrolizumab (Week 21), and then GPS + Montanide resumes Q3W for six additional doses (Weeks 24, 27, 30, 33, 36, 39). * Following the early immune booster, there is a 12-week interval of pembrolizumab administration (Weeks 42, 45, 48, 51), and then GPS is resumed every 12 weeks for an additional four doses. * After 84 weeks, participants who had not progressed will continue in the study and be treated with pembrolizumab alone.

Also known as: SLS-001, GPS, WT1 Analog Peptide Vaccine

Acute Myelogenous Leukemia (AML) - not openedColorectal Cancer (CRC) - opened but since only one subject enrolled, not included for analysesOvarian Cancer (OvC)Small Cell Lung Cancer (SCLC) - not openedTriple Negative Breast Cancer (TNBC) - not opened

pembrolizumabBIOLOGICAL

Pembrolizumab is administered at a dose of 200 mg intravenously every 3 weeks on Day 1 of each cycle (3-week cycles) starting on Study Week 6 and continuing for up to 2 years thereafter (Study Week 108). Pembrolizumab is to be administered no earlier than 30 minutes after the administration of GPS on Day 1 of each cycle.

Also known as: MK-3475, Keytruda

MontanideOTHER

Adjuvant

GM-CSFBIOLOGICAL

Participants receive 70 μg GM-CSF SC on Day -2 and on Day 1 before each GPS injection. The GM-CSF injections occur at the same anatomical site of the next planned study treatment injection.

Also known as: sargramostim

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Is willing and able to understand and provide signed informed consent for the study that fulfills IRB guidelines
Male or female patients \>18 years of age on the day of signing informed consent
Histologically or cytologically-confirmed advanced or metastatic solid tumors who have disease progression after treatment with available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment in the context of the particular line of treatment or, specifically for AML, demonstrate as their best response after 4 cycles of HMA therapy the status of "partial response" per European LeukemiaNet (ELN) criteria and meet the additional specified requirements for the cohort of the study they will enroll into.
All patients in the solid tumor arms will be tested for WT1 expression via IHC in their initial primary tumor OR recent biopsy of metastatic disease at the time of screening for study entry. Specifically for AML, patients will be tested for WT1 expression via IHC in their leukemic blasts either in the BM or PB. Assessment of WT1 expression positivity will be performed via central review prior to study entry.
Patients may have received a specific maximum allowable number of prior lines of therapy for metastatic disease, as follows: CRC: 2 or 3 lines; OvC: 1 or 2 lines; SCLC: 1 line; TNBC: 1 line; and AML: 1 line (allo-SCT-eligible status not allowed)
For solid tumor arms: patients must measurable disease based on RECIST v1.1 as determined by the local study team.
For AML arm, eligibility is defined as:
Prior frontline (1st line) with HMAs since initial AML diagnosis;
Prior cytoreductive therapy with hydroxyurea or leukapheresis at the time of initial diagnosis, with subsequent immediate seamless transitioning to HMA therapy
History of induction early failure after initial therapy with up to 2 cycles of standard chemotherapy ("7+3" or similar regimen), with subsequent immediate seamless transitioning to HMA therapy as long as patients have achieved PR as their best observable response after 4 cycles of HMA therapy; HMA therapy continues throughout the trial period.
Resolution of toxicity effect(s) from most recent prior chemotherapy to Grade 1 or less (except alopecia). If the patient received major surgery or radiation therapy of \> 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
(ECOG) performance status of 0 or 1.
For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 4 months following the last study treatment.
Have adequate organ function as defined:
+30 more criteria

You may not qualify if:

Presence of disease that is suitable for local or regional therapy administered with curative intent.
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
N.B.: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
N.B.: If the subject underwent major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Has received prior radiotherapy within 2 weeks of the start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE).
Subject currently participates in a clinical trial with another investigational agent and is receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first study treatment.
Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
Has undergone prior allogeneic hematopoietic stem cell transplantation.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. Steroids taken as short-term therapy (≤ 7 days) for antiemesis are permissible.
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years, even if currently inactive or unapparent.
\- N.B.: Specifically, AML patients with prior history of myelodysplastic syndromes or myeloproliferative neoplasms are not excluded. Participants in any of the study arms (solid tumors or AML) with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy, as well as patients with prostate cancer managed clinically with "watchful waiting" are eligible.
Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has known hypersensitivity to Montanide or vaccine adjuvants.
+14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

St. Joseph Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

Innovative Clinical Research Institute (ICRI)

Whittier, California, 90603, United States

Location

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

Location