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

Completed · Phase 1/Phase 2

Conditions studied: Acute Myelogenous Leukemia, Ovarian Cancer, Colorectal Cancer, Triple-negative Breast Cancer, Small-cell Lung Cancer

In brief

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

Key facts

Study ID

NCT03761914

Run by

Sellas Life Sciences Group

People needed

26

Starts

2019-09-30

Expected to finish

2022-10-27

Last updated by the study team

2024-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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:
• Absolute neutrophil count (ANC) ≥1500/µL
• Platelets ≥100,000/µL
• Hemoglobin (Hb) ≥9.0 g/dL or ≥5.6 mmol/L (N.B.: Hb criterion must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks)
• Creatinine ≤1.5 × upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥30 mL/min for subjects with creatinine levels >1.5 × institutional ULN
• Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5 × ULN
• AST (SGOT) and ALT (SGPT) ≤2.5 × ULN OR ≤5 × ULN for subjects with liver metastases
• International normalized ratio (INR) OR prothrombin time (PT) and Activated partial thromboplastin time (aPTT) ≤1.5 × ULN, unless subjects are receiving anticoagulant therapy as long as PT or aPTT is within the 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.

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.
• Had a previous clinically significant systemic allergic reaction to Montanide, sargramostim (GM-CSF), or filgrastim (G-CSF).
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• Has an active infection requiring systemic therapy.
• Subjects with known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA are excluded. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the participant 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 a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
• For female subjects: Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 30 days after the last dose of study treatment.
• Has had an allogeneic tissue/solid organ transplant.
• 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.

Where it is running

• St. Joseph Heritage Healthcare — Santa Rosa, California, United States
• Innovative Clinical Research Institute (ICRI) — Whittier, California, United States
• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States
• Memorial Sloan Kettering Cancer Center — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — Middletown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — Montvale, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — Commack, New York, United States
• Memorial Sloan Kettering Cancer Center — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — Nassau, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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