Non small cell lung cancer
Conditions
Interventions
Product Name: Keytruda
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Bank of Cyprus Oncology Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Be willing and able to provide written informed consent/assent for the trial. 2.Be > 18 years of age on day of signing informed consent. 3. Have measurable disease based on RECIST 1.1. 4. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. 5. Have a performance status of 0 to 2 on the ECOG Performance Scale. 6. Demonstrate adequate organ function as defined in Table 1 in the protocol, all screening labs should be performed within 10 days of treatment initiation. 7. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 8. Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 – Contraception, for the course of the study through 120 days after the last dose of study medication 9. Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1. Is currently participating and 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 dose of treatment. 2. Have completed more than six (6) cycles of first line platinum doublet chemotherapy or more than six (6) have elapsed from the last chemotherapy administration of the first line chemotherapy with platinum doublet. 3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 4. Has a known history of active TB (Bacillus Tuberculosis) 5. Hypersensitivity to pembrolizumab or any of its excipients. 6. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 7. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to a previously administered agent. 8. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 9. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. 10. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 11. Has known history of, or any evidence of active, non-infectious pneumonitis. 12. Has an active infection requiring systemic therapy. 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 16. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 17. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 18. Has known active Hepatitis B (e.g., HBsAg reactive) or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to provide efficacy data for Pembrolizumab as maintenance therapy after first line therapy for NSCLC. Especially relevant would be evidence of a higher percentage of patients being progression free at 1 year (primary endpoint), increased response rates, increased Progression free and Overall Survival (OS) compared to the results from other chemotherapy maintenance studies;Secondary Objective: Pembrolizumab can provide superior outcomes in terms of disease control / survival compared to its use in other lines of therapy.;Primary end point(s): Percentage of patients that have not progressed at 1 year using immune related radiological criteria. The 1 year timing relates to the time from trial enrollement and initiation of pembrolizumab as maintenance therapy. The timing of assessment at 1 year is based on the durable nature of responses seen with Pembrolizumab so far, suggesting that at 1 year there is going to be a large difference in disease progression between patients on Pembrolizumab compared to the historical data from the maintenance studies. ;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): These would include • Response rates (RECIST) • Response Rates with immune related Response Criteria (irRC) • Radiological Progression Free Survival (PFS) using RECIST criteria • Immune-related PFS using irRC: irPFS is the progression free survival (PFS) measured applying immune related radiological criteria. PFS (RECIST) at 6 months and 1 year from initiation of Pembrolizumab. • Overall survival • 1, 2 and 3 year OS rate. • Best overall response rate and disease control rate using both RECIST and irRC in patients with squamous and non-squamous NSCLC and • Immune-related toxicities (IRAEs) ;Timepoint(s) of evaluation of this end point: Depending on the endpoint 1, 2, and 3 year | — |
Countries
Cyprus
Contacts
Public ContactHaris Charalambous
Bank of Cyprus Oncology Center
Outcome results
None listed