Hematological
Absolute neutrophil count (ANC) | ≥1500/μL ≥ 1000/μL (hematological malignancies)
Platelets ≥ 100 000/μL | ≥ 75 000/μL (hematological malignancies)
Hemoglobin ≥.0 g/dL or ≥.6 mmol/La ≥8.0 g/dL or ≥5.0 mmol/La (hematological malignancies)
Renal
Hepatic
Coagulation
International normalized ratio (INR) OR prothrombin time (PT) | ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Activated partial thromboplastin time (aPTT)
ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.
Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion
within last 2 weeks.
Creatinine clearance (CrCl) should be calculated per institutional standard.
Note: This table includes eligibility-defining laboratory value requirements for Second Course Phase trial treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.
Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications of the intervention.
Male participant must agree to use contraception as detailed in Appendix 2 of this
protocol during the Second Course Phase trial treatment period and for at least
120 days, corresponding to time needed to eliminate any trial combination
treatment(s), plus 75 days (a spermatogenesis cycle) for trial treatments with
evidence of genotoxicity at any dose after the last dose of trial treatment and
refrain from donating sperm during this period.
A female participant is eligible to enroll if she is not pregnant (see Appendix 2,
not breastfeeding, and at least one of the following conditions applies: A woman
of childbearing potential (WOCBP) who agrees to follow the contraceptive
guidance in Appendix 2 during the trial treatment period and for at least 120 days
(corresponding to time needed to eliminate any trial combination treatment(s) plus
30 days (a menstruation cycle) for trial treatments with risk of genotoxicity.
Participants are excluded from entering Second Course trial treatment once they are enrolled on KN587 if any of the following criteria applies.
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 to the Cycle 1 Day 1 of Second Course Phase.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may enroll provided they are asymptomatic, not requiring the use of steroids at doses >10 mg/day prednisone or equivalent and have recovered adequately from the complications and/or toxicity of surgery or radiotherapy if required for their management.
Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, 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. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
NSCLC participants only: Has interstitial lung disease.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus infection.
Has a known history of or is positive for hepatitis B (hepatitis B surface antigen reactive) or hepatitis C (hepatitis C virus RNA [qualitative] is detected). Hepatitis C lab testing is allowed for eligibility purposes in countries where hepatitis C virus RNA is not part of SOC.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the Second Course Phase eligibility visit through 120 days after the last dose of trial treatment.
Has severe cardiovascular disease, ie,arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
Has hepatic decompensation (Child-Pugh score > 6 [class B and C]).
Has uncontrolled thyroid dysfunction.
Has uncontrolled diabetes mellitus.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's enrollment for the full duration of the trial, or is not in the best interest of the participant to enroll, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial (specific testing is not required).
Has had an allogeneic tissue/solid organ transplant.
Has a known history of active tuberculosis (TB; Bacillus tuberculosis).