Randomized Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Arcus Biosciences Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

5 Feb 2025 → ongoing

Decision date (initial)

2024-12-15

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Taiho Pharmaceutical Co., LTD.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To compare overall survival of quemliclustat + nab-paclitaxel and gemcitabine (NP-Gem) versus placebo + NP-Gem in all randomized patients.

Secondary objectives 3

1. To compare progression-free survival (PFS) of quemliclustat + NP-Gem vs placebo + NP-Gem in all randomized patients.
2. To assess additional measures of clinical activity in all randomized patients.
3. To assess the safety and tolerability of quemliclustat or placebo in combination with NP-Gem in all randomized patients.

Conditions and MedDRA coding

Pancreatic cancer

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Have histologically or cytologically confirmed PDAC that is metastatic.
2. Age ≥ 18 years (or age greater than or equal to regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
3. Have not been previously treated for PDAC in the metastatic setting. a. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization. b. Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and adverse events (AEs) have resolved to Grade 1 or less before randomization. Prior and/or placement of a biliary stent/tube is permitted if any treatment-related AEs have improved to Grade ≤ 1 and the patient is not exhibiting any signs/symptoms of biliary obstruction.
4. Eastern Cooperative Oncology Group PS of 0 to 1 within 7 days of randomization.
5. At least 1 target lesion measurable by computed tomography (CT)/magnetic resonance imaging (MRI) per RECIST v1.1. not within a field of prior radiation therapy.

Exclusion criteria 5

1. Previously treated for locally advanced, unresectable PDAC.
2. History of brain metastases or leptomeningeal metastases.
3. Prior treatment with a CD73 antagonist or inhibitor.
4. History of trauma or major surgery within 28 days prior to randomization.
5. History of ascites requiring therapeutic paracenteses or diuretics.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival is defined as the time from date of randomization until the date of death from any cause.

Secondary endpoints 5

1. Progression-free survival is defined as the time from the date of randomization until disease progression or death from any cause, whichever comes first, as measured per RECIST v1.1 as assessed by the investigator.
2. Objective response rate (ORR) is defined as the proportion of patients who have achieved best overall response of confirmed complete response (CR) or partial response (PR) to study therapy as assessed by the investigator according to RECIST 1.1.
3. Duration of response is defined as the time from the first objective response (CR or PR) until the date of first documented disease progression or death, whichever comes first, as measured per RECIST v1.1 as assessed by the investigator.
4. Disease control rate is defined as the proportion of patients who have achieved confirmed CR, confirmed PR, or stable disease for ≥ 8 weeks from the date of randomization, as assessed by the investigator according to RECIST 1.1.
5. The incidence and severity of adverse events and serious adverse events, and any clinically meaningful trends in safety parameters.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Arcus Biosciences Inc.

Sponsor organisation

Arcus Biosciences Inc.

Address

3928 Point Eden Way

City

Hayward

Postcode

94545-3719

Country

United States

Scientific contact point

Organisation

Arcus Biosciences Inc.

Contact name

Medical Director

Public contact point

Organisation

Arcus Biosciences Inc.

Contact name

Medical Director

Third parties 8

Locations

9 EU/EEA countries · 54 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 99 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

17 submissions — initial application plus substantial / non-substantial modifications