A Study of Pemetrexed Maintenance With or Without ADXS11-001 Immunotherapy in Patients With Human… (NCT02531854) | Clinical Trial Compass
WithdrawnPhase 2
A Study of Pemetrexed Maintenance With or Without ADXS11-001 Immunotherapy in Patients With Human Papillomavirus Positive (HPV+), NSCLC Following First-Line Induction Chemotherapy
Stopped: Study was withdrawn per sponsor decision
0Started 2018-12
Plain-language summary
* Open label
* Enrollment in the order of confirmation of eligibility and HPV+ tumor status
* Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR) mutation status, performance status and first-line induction chemotherapy outcome;
* Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus ADXS11-001 vs. 42 patients receiving pemetrexed alone)
* Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy
* Control Arm: Pemetrexed only
* Positive control: pemetrexed chemotherapy
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Male or female patients, ≥ 20 years of age
✓. Patients with NSCLC
✓. Patients whose disease has either responded or not progressed following 4-6 cycles of first-line induction chemotherapy.
✓. Patients with documented/confirmed intra-tumor positivity for HPV
✓. Patients with no major existing co-morbidities or medical conditions that will preclude administration of therapy, in the opinion of the Investigator
✓. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
✓. Patients will use contraception during the study
✓. Patients with the ability to understand and give written informed consent for participation in this trial
Exclusion criteria
✕. Women who are pregnant or breast feeding
✕. Patients with histologically- or cytologically-confirmed squamous cell-classified NSCLC
✕. Patients with disease progression following first-line induction chemotherapy
✕. Patients with known active and uncontrolled central nervous system (CNS) or leptomeningeal metastases
✕. Patients with an active second primary malignancy or history of another malignancy
What they're measuring
1
Number of study participants with objective tumor response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST)
Timeframe: 2 years
2
Number of study participants with progression free survival as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST)
✕. Patients with inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy, including ≥ Grade 2 neuropathy
✕. Patients with inadequate recovery from any previous surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to the start of study treatment
✕. Patients with evidence of inadequate organ function as defined in protocol