A Study to Evaluate the Combination of Nivolumab With ADG106 in Metastatic NSCLC

Trial number:
NCT05236608
Trial phase:
1, 2
Study type:
Immunotherapy, Chemotherapy
Overall status:
Recruiting

Study start date

November, 2021

Scientific title

A Phase 1b/2 Study to Evaluate the Combination of Nivolumab (Anti PD1 Monoclonal Ab) With ADG106 (4-1-BB Agonist Monoclonal Ab) in Metastatic NSCLC After Progression With antiPD1 Therapy and Platinum-based Chemotherapy (ADIVO Lung Study)

Summary

This is an open label, non-randomised phase 1b/2 study including patients with non-small cell lung cancer who have progressed after treatment with immune checkpoint inhibitors (anti PD1/PDL1 with or without CTLA4 inhibitors) and platinum-based chemotherapy. The study medications include nivolumab, an anti-PD1 inhibitor and ADG106, an agonist antibody of 4-1-BB. The investigators hypothesize that the combination of nivolumab and ADG106 would be tolerable, and demonstrate significant clinical anti-tumour activity in patients with NSCLC that has failed antiPD1/antiPDL1 immunotherapy and standard platinum-based chemotherapy. The investigators propose to conduct a phase 1b/2 study to investigate this strategy.

For Phase 1b: Patients with histologically or cytologically confirmed solid malignancies

who are refractory to standard of care treatment ORhave no standard of care treatment of curative potential.

For Phase 2: Patients with histologically or cytologically confirmed stage 4 or recurrent NSCLC (per IASLC classification) who have progression of disease

after treatment with antiPD1/PDL1 with CTLA4 inhibitors and at least one platinum-based chemotherapy ORafter treatment with antiPD1/PDL1 without CTLA4 inhibitors and at least one platinum-based chemotherapy The participant (or legally acceptable representative if applicable) provides written consent for the trial. Participants who are at least 21 years of age on the day of signing informed consent. Eastern Cooperative Group (ECOG) Performance Status 0-1 Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Previously irradiated lesions is considered measurable if they show progression after completion of radiation therapy. Have adequate organ function. Specimens must be collected within 7 days prior to the start of study treatment.

A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

Not a woman of childbearing potential ORA woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study medication. A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. Willing to participate in the translational blood and tissue collection studies. Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumour tissue block or unstained tumour tissue specimens if fresh tumour biopsy is not feasible.

Study design

Primary purpose: Treatment, Allocation: N/A, Intervention model: Single Group Assignment, Masking: None (Open Label),

Conditions

Metastatic Non Small Cell Lung Cancer

Other study ID numbers

STCC-02; CA209-63C; ADG106-T6001

Choose trial site (3)