Clareo Health | GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genome & Company
With
Merck KGaA, Darmstadt, Germany
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have adequate organ functions as defined in the protocol
Negative childbearing potential
Have ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities
Patients with diseases for which no curative therapies are available, and who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination)
Disease progression on anti-PD-(L)1 based therapy (as monotherapy or combination therapy) and must meet criteria for acquired resistance as defined in the protocol
Patients who have completely recovered from any clinically significant AEs that occurred during prior immunotherapy
Estimated life expectancy of at least 3 months
Objective evidence of disease progression at baseline (Dose Escalation)
Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic NSCLC, SCCHN, and UC (Dose Expansion)
Measurable disease as per RECIST v1.1 defined as at least 1 lesion (Dose Expansion)
You may not be if
Have experienced primary resistance to anti-PD-(L)1 based therapy
Has experienced a toxicity that led to permanent discontinuation of prior anti-PD-(L)1 based therapy or other immunotherapies
Has active autoimmune disease that has required systemic treatment in the past 2 years
Current use of immunosuppressive medication at time of study entry
Have an active infection requiring antibiotics, antifungal or antiviral agents or have received a course of antibiotics within the previous 4 weeks of starting study treatment
Has received a live vaccine within 4 weeks of starting of study treatment
Known history of, or any evidence of active, non-infectious pneumonitis
Prior solid organ or allogeneic stem cell transplantation
Has had any investigational or anti-tumor treatment within 4 weeks or 5 half-life periods of starting study treatment, had any major surgeries within 4 weeks of starting study treatment
Has received proton pump inhibitors (PPIs) within 2 weeks prior to dosing study treatments
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has clinically significant (i.e., active) cardiovascular disease
Has known history of uncontrolled intercurrent illness
Has any psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with study requirements.
