Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18 years (≥ 20 years in Japan; ≥ 19 years in South Korea)
Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate bone marrow function, renal and liver functions Phase 1b
Histological or Cytological diagnosis of advanced solid tumor with clinical evidence of response to anti-PD-1 or PD-L1 agent
Participant must have received at least 1 prior line of therapy for recurrent or metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to standard therapy approved for the specific tumor type Phase 2
Participants must have a documented diagnosis of stage III where participants are not candidates for surgical resection or definitive chemoradiation, or stage IV NSCLC
EGFR mutation, BRAF mutation, and ALK or ROS1 translocation/rearrangement are not permitted
Participants whose tumor is known to be PD-L1 positive (Tumor Proportion Score \[TPS\] ≥1%) or unknown are eligible
Up to 1 line of prior therapy in advanced or metastatic disease settings allowed
Participant should not have received prior treatment with anti PD-1/PD-L1 drugs
At least one measurable lesion as defined by RECIST version 1.1
You may not be if
Participants with known symptomatic brain metastases requiring steroids
Participants with Interstitial Lung Disease history or complication
Q-T interval corrected for heart rate QTc \> 450 msec for male participants or QTc \> 470 msec for female participants or QTc \> 480 msec in participants with right bundle branch block.
Hypertension that cannot be controlled by medications (eg, systolic \> 150 mmHg and diastolic \> 90 mmHg) despite optimal medical therapy.
Known or suspected hypersensitivity to active ingredient or excipients of the study drug.
History of Grade ≥3 immune mediated AE (including AST/ ALT elevations that where considered drug related and cytokine release syndrome \[CRS\]) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b only).
Vaccination with live attenuated vaccines within 4 weeks prior to randomization is prohibited; however inactivated vaccines are permitted.
Clareo Health | Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies
