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This is an open label, multi-institutional, single arm study with a dose escalation phase Ib cohort, followed by a phase II cohort of pembrolizumab and Imprime PGG. No randomization or blinding is involved.
Full description
OUTLINE: This is a multi-center study.
The phase Ib dose escalation will evaluate the combination of pembrolizumab and Imprime PGG for subjects with metastatic non-small cell lung cancer (NSCLC) after progression on first-line platinum-based chemotherapy. The phase II trial will test whether addition of Imprime PGG to pembrolizumab will increase median progression-free survival (PFS) in second line therapy setting in NSCLC.
PHASE Ib DOSE ESCALATION INVESTIGATIONAL TREATMENT:
Cohort 1 will consist of 3-6 patients who will receive
Cohort 2 will consist of 3-6 patients who will receive
If none of the 3 subjects experience a dose limiting toxicity (DLT) during the first cycle of therapy, an additional three subjects will be enrolled at dose level 2. If all subjects in dose level 2 complete the first cycle of therapy without DLT, 3 more subjects will be enrolled into dose level 2 to ensure only 0-1 of 6 subjects have a DLT. There will be no further escalation beyond dose level 2.
PHASE II INVESTIGATIONAL TREATMENT:
Pembrolizumab will be given on Day 1 of each 21 day cycle after Imprime PGG, and the RP2D dose of Imprime PGG will be given on Days 1, 8 and 15 of each 21 day cycle. Treatment will continue up to 16 cycles, or until disease progression, unacceptable toxicity, subject refusal, or subject death either from progression of disease, the therapy itself, or from other causes.
Life expectancy: of 6 months or greater
The following baseline labs must be completed within 28 days prior to registration for protocol therapy:
Hepatic:
Renal:
Hematopoietic:
Coagulation:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female ≥ 18 years of age at time of consent.
Subjects with histologically or cytologically confirmed non-small cell lung cancer (NCSLC).
Subjects with stage IV non-small cell lung cancer as defined by American Joint Committee on Cancer (AJCC).
Phase Ib: Subjects who progressed after first-line platinum-based chemotherapy and who are candidates for second-line therapy.
Phase II: Subjects who have progressed on first-line systemic therapy (either platinum-based chemotherapy with or without immune checkpoint inhibitor or immune checkpoint inhibitor as first line therapy) who are candidates for second-line systemic therapy. Patients with early stage cancer will also be eligible if progression occurs:
Phase II: Subjects with an EGFR or ALK mutation who are no longer candidates for TKI therapy and have progressed on standard systemic therapy (either platinum-based chemotherapy with or without immune checkpoint inhibitor or immune checkpoint inhibitor as first line therapy).
Phase II only: Measurable disease according to RECIST v1.1 (Section 8) obtained by imaging within 28 days prior to study registration. Phase Ib: subjects may enroll with or without measurable disease.
Phase II only: Subjects must have presence of peripheral blood levels of IgG anti-β-glucan antibody (ABA) of ≥ 20 μg/mL as determined by an ELISA test within 90 days prior to study registration.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 28 days prior to study registration.
Life expectancy of 6 months or greater as determined by the treating physician.
Adequate hepatic function within 28 days prior to study registration defined as meeting all of the following criteria:
Adequate renal function within 28 days prior to study registration defined by either of the following criteria:
Adequate hematologic function within 28 days prior to study registration defined as meeting all of the following criteria:
Adequate coagulation functioning within 28 days prior to study registration defined by either of the following criteria:
Provided written informed consent and HIPAA authorization for release of personal health information, approved by an Institutional Review Board (IRB). NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Women of childbearing potential (WOCP) must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required within 72 hours of study registration. If the urine test cannot be confirmed as negative, a serum pregnancy test will be required.
Women of childbearing potential (WOCP) must be willing to use two effective methods of birth control such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence for the course of the study until 120 days after the last dose of study drug. NOTE: Women are considered to be of childbearing potential unless they are postmenopausal (≥45 years of age and has not had menses for greater than 12 consecutive months), surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or not heterosexually active for the duration of the study and at least 120 days after the last dose of study drug.
Men who are not surgically sterile (vasectomy) must agree to use an acceptable method of contraception. Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the first dose of study drug through at least 120 days after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.
Willingness and ability to comply with scheduled visits (including geographical distance), treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
35 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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