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Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers

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ClinicalTrials.gov Identifier: NCT03761914
Recruitment Status : Not yet recruiting
First Posted : December 3, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Cancer Insight, LLC
Information provided by (Responsible Party):
Sellas Life Sciences Group

Brief Summary:
To evaluate the safety and tolerability of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers. Patients will be followed long-term for OS and safety. The study will enroll approximately 90 patients and maximum study treatment duration is approximately 2.13 years.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Ovarian Cancer Colorectal Cancer Triple-negative Breast Cancer Small-cell Lung Cancer Biological: galinpepimut-S Drug: Pembrolizumab Phase 1 Phase 2

Detailed Description:

This is a Phase 1/2, open-label, non-comparative, multicenter, multi-arm study of the Wilms Tumor-1 (WT1)-targeting multivalent heteroclitic peptide immunotherapeutic vaccine galinpepimut-S in combination with the programmed death-1 (PD1) inhibitor pembrolizumab in patients with selected advanced cancers. This study will assess the efficacy and safety of galinpepimut-S and pembrolizumab and investigate the effect of galinpepimut-S and pembrolizumab on various tumor types. Patients will be followed long-term for OS and safety. The study will enroll approximately 90 patients at up to 20 centers in the United States.

Indications treated are colorectal (third or fourth line), ovarian (second or third line), small cell lung cancer (second line), breast cancer (triple negative; second line), acute myelogenous leukemia (unable to attain deeper morphological response than partial [PR] on hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant).

The first 2 galinpepimut-S injections will initially be administered as monotherapy every 3 weeks (Week 0 and Week 3). Thereafter, galinpepimut-S will be co-administered with pembrolizumab every 3 weeks for 4 additional administrations (for the galinpepimut-S initial immunization induction phase series; weeks 6-15) to coincide with the per label pembrolizumab dosing frequency. After that, there will be one un-paired administration of pembrolizumab (week 18), and then galinpepimut-S will be resumed on an every 3-week schedule for 6 additional doses (early immune booster phase; weeks 21-36). At the end of this phase, there will be a 12-week interval where 3 unpaired administrations of pembrolizumab will occur (weeks 39-45), and then galinpepimut-S will be resumed on an every 12-week schedule for 4 additional doses (late immune booster phase; weeks 48-84). After 84 weeks, continuing non-progressed patients will be treated with pembrolizumab alone up until week 111.

Pembrolizumab will be 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 111). Pembrolizumab will be administered no earlier than 30 minutes after the administration of galinpepimut-S on Day 1 of each cycle where the 2 drugs are being co-administered.


Study Type : Interventional
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 1/2, open-label, non-comparative, multicenter, multi-arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers
Estimated Study Start Date : December 15, 2018
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : January 15, 2021


Arm Intervention/treatment
Experimental: Colorectal Cancer (CRC)
  • N=20;
  • Subjects with metastatic CRC previously treated with ≥2 lines of prior systemic chemotherapy (3rd/4th line population);
  • PFS and OS to be assessed in all;
  • Patients will receive GM-CSF before each galinpepimut-S vaccine injection. The first 2 vaccine injections will be administered as monotherapy every 3 weeks. Thereafter, the vaccine will be co-administered with pembrolizumab every 3 weeks for another 4 administrations. After that, there will be one unpaired administration of pembrolizumab, and then the vaccine will be resumed on an every 3-week schedule for 6 additional doses. At the end of this phase, there will be a 12-week interval where 3 unpaired administrations of pembrolizumab will occur, and then the vaccine will be resumed every 12 weeks for an additional 4 doses. After 84 weeks, patients who have not progressed will continue in the study and will be treated with pembrolizumab alone.
Biological: galinpepimut-S
Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
Other Names:
  • SLS-001
  • GPS
  • WT1 Analog Peptide Vaccine

Drug: Pembrolizumab
Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
Other Names:
  • MK-3475
  • Keytruda

Experimental: Ovarian Cancer (OvC)
  • N=20;
  • Patients with metastatic OvC previously treated with ≥1 line of prior systemic chemotherapy (2nd/3rd line population);
  • PFS and OS to be assessed in all;
  • Patients will receive GM-CSF before each galinpepimut-S vaccine injection. The first 2 vaccine injections will be administered as monotherapy every 3 weeks. Thereafter, the vaccine will be co-administered with pembrolizumab every 3 weeks for another 4 administrations. After that, there will be one unpaired administration of pembrolizumab, and then the vaccine will be resumed on an every 3-week schedule for 6 additional doses. At the end of this phase, there will be a 12-week interval where 3 unpaired administrations of pembrolizumab will occur, and then the vaccine will be resumed every 12 weeks for an additional 4 doses. After 84 weeks, patients who have not progressed will continue in the study and will be treated with pembrolizumab alone.
Biological: galinpepimut-S
Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
Other Names:
  • SLS-001
  • GPS
  • WT1 Analog Peptide Vaccine

Drug: Pembrolizumab
Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
Other Names:
  • MK-3475
  • Keytruda

Experimental: Small Cell Lung Cancer (SCLC)
  • N=20;
  • This arm includes patients with advanced SCLC previously treated with 1 line of prior systemic chemotherapy (2nd line population);
  • PFS and OS to be assessed in all;
  • Patients will receive GM-CSF before each galinpepimut-S vaccine injection. The first 2 vaccine injections will be administered as monotherapy every 3 weeks. Thereafter, the vaccine will be co-administered with pembrolizumab every 3 weeks for another 4 administrations. After that, there will be one unpaired administration of pembrolizumab, and then the vaccine will be resumed on an every 3-week schedule for 6 additional doses. At the end of this phase, there will be a 12-week interval where 3 unpaired administrations of pembrolizumab will occur, and then the vaccine will be resumed every 12 weeks for an additional 4 doses. After 84 weeks, patients who have not progressed will continue in the study and will be treated with pembrolizumab alone.
Biological: galinpepimut-S
Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
Other Names:
  • SLS-001
  • GPS
  • WT1 Analog Peptide Vaccine

Drug: Pembrolizumab
Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
Other Names:
  • MK-3475
  • Keytruda

Experimental: Triple Negative Breast Cancer (TNBC)
  • N=15;
  • Patients with TNBC previously treated with 1 line of prior systemic chemotherapy (2nd line population);
  • PFS and OS to be assessed in all;
  • Patients will receive GM-CSF before each galinpepimut-S vaccine injection. The first 2 vaccine injections will be administered as monotherapy every 3 weeks. Thereafter, the vaccine will be co-administered with pembrolizumab every 3 weeks for another 4 administrations. After that, there will be one unpaired administration of pembrolizumab, and then the vaccine will be resumed on an every 3-week schedule for 6 additional doses. At the end of this phase, there will be a 12-week interval where 3 unpaired administrations of pembrolizumab will occur, and then the vaccine will be resumed every 12 weeks for an additional 4 doses. After 84 weeks, patients who have not progressed will continue in the study and will be treated with pembrolizumab alone.
Biological: galinpepimut-S
Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
Other Names:
  • SLS-001
  • GPS
  • WT1 Analog Peptide Vaccine

Drug: Pembrolizumab
Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
Other Names:
  • MK-3475
  • Keytruda

Experimental: Acute Myelogenous Leukemia (AML)
  • N=15;
  • Pts with AML who are not eligible for allogeneic stem cell transplant and have only been able to achieve morphological PR while receiving frontline therapy with HMAs;
  • PFS and OS to be assessed in all;
  • Patients will receive GM-CSF before each galinpepimut-S vaccine injection. The first 2 vaccine injections will be administered as monotherapy every 3 weeks. Thereafter, the vaccine will be co-administered with pembrolizumab every 3 weeks for another 4 administrations. After that, there will be one unpaired administration of pembrolizumab, and then the vaccine will be resumed on an every 3-week schedule for 6 additional doses. At the end of this phase, there will be a 12-week interval where 3 unpaired administrations of pembrolizumab will occur, and then the vaccine will be resumed every 12 weeks for an additional 4 doses. After 84 weeks, patients who have not progressed will continue in the study and will be treated with pembrolizumab alone.
Biological: galinpepimut-S
Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
Other Names:
  • SLS-001
  • GPS
  • WT1 Analog Peptide Vaccine

Drug: Pembrolizumab
Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
Other Names:
  • MK-3475
  • Keytruda




Primary Outcome Measures :
  1. Number and frequency of TRAEs, including UARs, and SAEs (safety parameters) - for all tumor types [ Time Frame: First 9 weeks up to 32 months ]
    Define the absolute number, relative frequency, and severity (grade) of treatment-related adverse events (TRAEs), including unexpected adverse reaction (UARs), as well as serious adverse events (SAEs) -irrespective of relationship to study drug - using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. for all patients on study.

  2. Overall response rate (ORR) by RECIST - for solid tumor arms [ Time Frame: First 9 weeks up to 32 months ]
    The anti-tumor activity of the combination of galinpepimut-S and pembrolizumab as defined by Response Evaluation Criteria in Solid Tumors (RECIST) to determine if the observed activity is sufficiently promising to evaluate the combination in future clinical studies.

  3. Complete Response (CR) rate - for AML arm only [ Time Frame: First 9 weeks up to 32 months ]
    Rate (frequency or percentage) of achievement of morphological/hematologic CR in the AML arm of the trial to determine if the observed activity is sufficiently promising to evaluate the combination in future clinical studies in AML patients on hypomethylators.

  4. Overall response rate (ORR) by iRECIST - for solid tumor arms [ Time Frame: First 9 weeks up to 32 months ]
    The anti-tumor activity of the combination of galinpepimut-S and pembrolizumab as defined by Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) to determine if the observed activity is sufficiently promising to evaluate the combination in future clinical studies.

  5. Measurable Residual Disease (MRD) negativity rate - for AML arm only [ Time Frame: First 9 weeks up to 32 months ]
    Rate (frequency or percentage) of achievement of MRD(-) status, as assessed by multigene MRD assay, in the AML arm of the trial. In more detail, calculation of the percentage of patients who achieve hematologic CR who also have evidence of deep molecular response (i.e., achieve MRD negativity). This information along with the rate of hematologic CR will help inform on the design of future studies investigating this combination in AML patients on hypomethylators.


Secondary Outcome Measures :
  1. Time to response (TTR) - for all tumor types [ Time Frame: First 9 weeks up to 32 months ]
    Evaluate the clinical benefit of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers through the analysis of time to response (TTR).

  2. Time to next treatment (TNT) - for all tumor types [ Time Frame: First 9 weeks up to 32 months ]
    Evaluate the clinical benefit of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers through the analysis of time to next treatment (TNT).

  3. Duration of Response (DOR) - for solid tumor arms [ Time Frame: First 9 weeks up to 32 months ]
    Evaluate the clinical benefit of galinpepimut-S in combination with pembrolizumab in patients with selected advanced solid malignancies through the analysis of duration of response (DOR), based on the interval of time between the documentation of ORR (CR/PR) and documentation of progressive disease (PD).

  4. Duration of CR - for AML arm only [ Time Frame: First 9 weeks up to 32 months ]
    Evaluate the clinical benefit of galinpepimut-S in combination with pembrolizumab in patients with AML through the analysis of duration of complete response, based on the interval of time between the documentation of CR and documentation of morphological leukemic relapse/progressive disease (PD).


Other Outcome Measures:
  1. Immune Response (IR) to WT1 peptides within the vaccine mixture - Galinpepimut-S Pharmacodynamics - Exploratory endpoint - for all tumor types [ Time Frame: Baseline (pre-treatment) and first 9 weeks up to 32 months (post-treatment) ]
    WT1 (epitope/antigen)-specific T-cell (CD8 and CD4) immune response dynamics in peripheral blood (PB) and select general immunodynamics assessments (in PB and tissue samples, as applicable; e.g., immunophenotyping of lymphocyte & NK cell subpopulations in PB via flow cytometry).

  2. PD Ligand 1 (PDL-1) expression in malignant tissue biopsy samples - Pembrolizumab Pharmacodynamics - Exploratory Exploratory endpoint - for solid tumor arms [ Time Frame: Baseline (pre-treatment) and first 9 weeks up to 32 months (post-treatment) ]
    Programmed death-ligand 1 (PD-L1), also known as cluster of differentiation 274 (CD274) or B7 homolog 1 (B7-H1), expression in malignant tissue biopsy samples by a validated assay (for solid tumors only).

  3. PD Ligand 1 (PDL-1) expression in bone marrow biopsy samples - Pembrolizumab Pharmacodynamics - Exploratory Exploratory endpoint - for AML arm only [ Time Frame: Baseline (pre-treatment) and first 9 weeks up to 32 months (post-treatment) ]
    Programmed death-ligand 1 (PD-L1), also known as cluster of differentiation 274 (CD274) or B7 homolog 1 (B7-H1), expression in bone marrow biopsy samples by a validated assay (for AML arm only).

  4. Progression-free survival (PFS) - Exploratory endpoint - for solid tumor arms [ Time Frame: Up to 32 months ]
    From time of registration to the time of documented disease progression per RECIST 1.1 or subject death (for solid tumors).

  5. Progression-free survival (PFS) - Exploratory endpoint - for AML arm only [ Time Frame: Up to 32 months ]
    From time of registration to the time of documented morphological leukemic relapse or subject death. PFS is equivalent to leukemia-free survival (LFS) (for AML arm only).

  6. Overall survival (OS) - Exploratory endpoint - for all tumor types [ Time Frame: Up to 32 months ]
    From time of registration to the time of subject death.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • Has 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 will be tested for WT1 expression via IHC in both their initial primary tumor and recent biopsy of metastatic disease at the time of screening for study entry, or, specifically for AML, leukemic blasts either in the BM or PB.
  • 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)
  • Have measurable disease based on RECIST v1.1 as determined by the local study team.
  • AML patients are allowed to have undergone prior chemotherapy (other than HMAs), but should have received the last dose of their most recent chemotherapy regimen at least 28 days prior to first galinpepimut-S administration.
  • 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:

    • Absolute neutrophil count (ANC)≥1,500 /mcL
    • Platelets ≥100,000 / mcL
    • Hemoglobina ≥ 9 g/dL or ≥5.6 mmol/L,
    • Renal Creatinine OR Measured or calculated creatinine clearance ≤ 1.5 ULN OR ≥ 30 mL/min for patient with creatinine levels >1.5 institutional ULN
    • Total bilirubin ≤1.5 ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5ULN.
    • AST (SGOT) and ALT (SGPT) ≤ 2.5ULN OR ≤ 5ULN for patients with liver metastases
    • INR or PT/PTT ≤1.5 ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Additional Inclusion Criteria for Selected Tumor Types:

(i).Colorectal Cancer (third/fourth line)

  • Histologically or cytologically documented adenocarcinoma of colon or rectum at the time of initial presentation.
  • Metastatic CRC with documented disease progression (per standard criteria) after the last administration of standard therapies or intolerance to standard therapies (and approved therapies must have included all the following a fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and, if KRAS wild-type, cetuximab or panitumumab). Prior use of and failure after regorafenib or trifluridine/tipiracil is allowed but not mandated.

(ii). OvC (second/third line)

  • Histologically diagnosed ovarian, fallopian tube or primary peritoneal cancer at the time of initial presentation.
  • Patients will have either relapsed or be disease resistant to their prior therapy. Interval surgery is permitted, but patients must have objective evidence of disease on computed tomography (CT)or magnetic resonance imaging (MRI), with concomitant CA-125 increase and/or biopsy showing OvC (only for recurrent disease).

(iii). SCLC(second line)

  • Histologically or cytologically confirmed SCLC based on biopsy of the tumor at initial presentation.
  • Asymptomatic or treated brain metastases are allowed.
  • Patients must have measurable disease(by CT or MRI) after they progressed or were resistant to 1 prior systemic therapy.

(iv). TNBC (second line)

  • Histologically proven metastatic breast carcinoma with triple negative receptor status.
  • Patients must have measurable disease(by CT or MRI) after they progressed or were resistant to 1 prior systemic therapy.
  • Patients have undergone second line therapy after residual or recurrent disease after first line therapy.

    (v). AML

  • Pathologically or morphologically confirmed de novo or secondary AML at the time of initial diagnosis.
  • Achievement of no better than morphologic PR, as defined initially by the AML Working Group criteria (Cheson et al,2003), and also quoted in the more recent ELN criteria (Döhner et al, 2010),while on active treatment with HMAs.
  • AML patients are eligible only if they received first line therapy with HMAs (decitabine or azacytidine) for 4 cycles and achieved only PR at the end of cycle 4.
  • AML patients shall remain on HMA therapy.

Exclusion Criteria:

  • Has disease that is suitable for local therapy administered with curative intent.
  • Is currently participating and 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 a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10mg daily of prednisone equivalentor a maximum dose of a corticosteroid not to exceed 10 mg). Steroids taken as short-term therapy (≤7 days) for antiemesis are permissible.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first study treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 3 months prior to first study treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to a previously administered agent.

Note: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.

Note: If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study drugs.

  • Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (excluding GM-CSF, but including G-CSF or recombinant erythropoietin) within 4 weeks prior to first study treatment.
  • Has a known additional malignancy that is progressing or requires active treatment.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases and/or carcinomatous meningitis may participate provided they are clinically stable for at least 2 weeks and, have no evidence of new or enlarging brain metastases, AND are also off steroids 3 days prior to first study treatment. Subjects with known untreated, asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion >1.5 cm) may participate but will require regular imaging of the brain as a site of disease.
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) or history of an autoimmune disease that required immune suppressive therapy, such as but not limited to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. History of vitiligo is permissible. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Has a history of interstitial lung disease(ILD).
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. This includes any serious, intercurrent, chronic, or acute illness, such as cardiac disease (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the investigator as an unwarranted high risk for investigational drug treatment.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial or judged by the treating investigator that such disorders could possibly lead to noncompliance with the protocol.
  • A WOCBP who has a positive urine pregnancy test (e.g., within 72 hours prior to treatment). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
  • 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 irAE.
  • Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
  • Has known active hepatitis B (e.g., hepatitis B antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [HCV RNA] [qualitative] is detected).
  • 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 severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
  • Has known hypersensitivity to Montanide or vaccine adjuvants.
  • Had a previous clinically significant systemic allergic reaction to Montanide, sargramostim (GM-CSF), or filgrastim (G-CSF).

Additional Exclusion Criteria for Selected Tumor Types:

(i). CRC: None (ii). OvC: None (iii). SCLC: Mixed SCLC (iv). TNBC: None (v). AML:

  1. Planned/anticipated HSCT (autologous or allogeneic, with any degree of match donor); acute promyelocytic leukemia (APL; M3 or any morphologic and molecular variants, inclusive); history of, or current diagnosis of CNS leukemia
  2. Second line patients or patients who received any chemotherapy ("3 + 7" regimen) and subsequently switch to HMAs are ineligible for enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761914


Contacts
Contact: Katie Lyon, MS, CCRP 210-952-6301 klyon@cancerinsight.com
Contact: Sherri Thomas, RN,BSN,CCRP 210-844-5861 sthomas@cancerinsight.com

Sponsors and Collaborators
Sellas Life Sciences Group
Merck Sharp & Dohme Corp.
Cancer Insight, LLC
Investigators
Study Director: Nicholas J Sarlis, MD, PhD SELLAS Life Sciences Group, Inc.

Responsible Party: Sellas Life Sciences Group
ClinicalTrials.gov Identifier: NCT03761914     History of Changes
Other Study ID Numbers: SLS17-201/MK3475-770
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sellas Life Sciences Group:
peptide vaccine
immuno-oncology
WT1-expressing tumors
galinpepimut-S
pembrolizumab
PD1 inhibitor
checkpoint inhibitor
combination immunotherapy
heteroclitic
multivalent
off-the-shelf vaccine
HLA allele
WT1 vaccine
SLS-001
WT1 analog peptide vaccine

Additional relevant MeSH terms:
Colorectal Neoplasms
Leukemia, Myeloid
Small Cell Lung Carcinoma
Triple Negative Breast Neoplasms
Leukemia, Myeloid, Acute
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leukemia
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Breast Neoplasms
Breast Diseases
Skin Diseases
Vaccines
Pembrolizumab
Immunologic Factors