A Phase 2 Clinical Trial Evaluating the Efficacy and Safety of Dual Immune Checkpoint Inhibition With Anti-PD-L1 (Atezolizumab) and Anti-TIGIT (Tiragolumab) in Cancer of Unknown Primary

M.D. Anderson Cancer Center2 sites in 1 country4 target enrollmentApril 11, 2025

ConditionsCancer

InterventionsAtezolizumab Tiragolumab

DrugsAtezolizumab Tiragolumab

Overview

Phase: Phase 2
Intervention: Atezolizumab
Conditions: Cancer
Sponsor: M.D. Anderson Cancer Center
Enrollment: 4
Locations: 2
Primary Endpoint: Safety and Adverse Events (AEs)
Status: Active, not recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical research study is to learn if the combination of atezolizumab and tiragolumab can help to control cancers of unknown primary. The safety and effects of this drug combination will also be studied

Detailed Description

Primary Objectives: To assess the anti-tumor activity of tiragolumab and atezolizumab in patients with CUP. Primary Endpoint: confirmed ORR as per RECISTv1.1. Secondary Objectives: To assess the best objective response rate (ORR) (investigator assessed), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS) overall survival (OS) in patients with CUP. Secondary Endpoints: Best overall response rate per RECISTv1.1 (investigator assessed), DCR, DOR, PFS, and OS

Registry

clinicaltrials.gov

Start Date

April 11, 2025

End Date

July 1, 2029

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

M.D. Anderson Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•● Patients must have histopathological confirmed unresected, locally advanced, recurrent, or metastatic CUP. Patients must have undergone standard work-up to attempt to find the primary tumor prior to enrollment.
•Patients must be refractory or intolerant to at least one line of systemic chemotherapy or ineligible for cytotoxic chemotherapy.
•Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
•Age ≥18 years. Because no dosing or adverse event data are currently available on the use of tiragolumab in combination with atezolizumab in patients \<18 years of age, children are excluded from this study.
•ECOG performance status of 0-
•Patients must have adequate organ and marrow function as defined below:
•ANC \> 1.5 x 109 /L (1500/L) without granulocyte colony-stimulating factor support.
•Lymphocyte count \> 0.5 x 109 /L (500/L).
•Platelet count \> 100 x 109 /L (100,000/L) without transfusion.
•Hemoglobin \> 90 g/L (9 g/dL).

Exclusion Criteria

•Patients who have received treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, LAG-3inhibitor, or anti-CTLA-4 antibody, or any other antibody or drug that specifically targets Tcell co-stimulation or immune checkpoint pathways.
•Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e.,have residual toxicities \> NCI CTCAE v5.0 Grade 1) with the exception of alopecia, events that are not clinically significant, or asymptomatic laboratory abnormalities.
•Patients who are receiving any other investigational agents.
•History of leptomeningeal disease
•Uncontrolled tumor-related pain
•Patients requiring pain medication must be on a stable regimen at study entry.
•Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
•Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Patients with indwelling catheters (e.g., PleurX) are allowed.
•Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \<12 mg/dL or corrected serum calcium \> ULN)