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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03719326




Registration number
NCT03719326
Ethics application status
Date submitted
15/10/2018
Date registered
25/10/2018

Titles & IDs
Public title
A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies
Scientific title
A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast or Gynecologic Malignancies
Secondary ID [1] 0 0
ARC-2 (AB928CSP0002)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
TNBC - Triple-Negative Breast Cancer 0 0
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etrumadenant
Treatment: Drugs - IPI-549
Treatment: Drugs - Pegylated liposomal doxorubicin (PLD)
Treatment: Drugs - nanoparticle albumin-bound paclitaxel (NP)

Experimental: Dose Escalation-Arm A - Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.

Experimental: Dose Escalation-Arm B - Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.

Experimental: Dose Escalation-Arm C - Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.

Experimental: Dose Expansion-TNBC-Arm 1 - The dose given will be determined from the dose escalation part (Arm A).

Experimental: Dose Expansion-Ovarian Cancer-Arm 2 - The dose given will be determined from the dose escalation part (Arm A).

Experimental: Dose Expansion-TNBC-Arm 3 - The dose given will be determined from the dose escalation part (Arm B). .

Experimental: Dose Expansion-TNBC-Arm 4 - The dose expansion will be determined from the dose escalation part (Arm C).


Treatment: Drugs: Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist for oral use

Treatment: Drugs: IPI-549
IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use

Treatment: Drugs: Pegylated liposomal doxorubicin (PLD)
Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use

Treatment: Drugs: nanoparticle albumin-bound paclitaxel (NP)
NP is a microtubule inhibitor for intravenous (IV) use
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
From first dose date to 30 days after the last dose (Approximately 1 year)
Primary outcome [2] 0 0
Incidence of dose-limiting toxicities (DLTs) during the dose escalation phase
Timepoint [2] 0 0
From first dose date to 28 days after the first dose
Secondary outcome [1] 0 0
Plasma concentration of etrumadenant
Timepoint [1] 0 0
Recorded at baseline (prior to first dose), during the first 4 cycles of treatment (4 months) and at the end of treatment (i.e. in total approximately 5 months)
Secondary outcome [2] 0 0
Plasma concentration of IPI-549
Timepoint [2] 0 0
Recorded at baseline (prior to first dose), during the first 4 cycles of treatment (4 months) and at the end of treatment (i.e. in total approximately 5 months)
Secondary outcome [3] 0 0
Percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), as determined by Investigator according to Response Evaluation in Solid Tumors (RECIST) v 1.1
Timepoint [3] 0 0
From study enrollment until participation discontinuation, first occurrence of progressive disease or death from any cause, whichever occurs first (approximately 3-5 years)
Secondary outcome [4] 0 0
Percentage of participants with Disease Control (complete response, partial response, or stable disease) for > 6 months as determined by RECIST v1.1
Timepoint [4] 0 0
From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Secondary outcome [5] 0 0
Duration of Response as determined by the Investigator according to RECIST v1.1
Timepoint [5] 0 0
From the date of the first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary outcome [6] 0 0
Progression Free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Timepoint [6] 0 0
From start of the treatment up to first occurrence of progressive disease or death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary outcome [7] 0 0
Overall Survival (OS) as determined by the Investigator according to RECIST v1.1
Timepoint [7] 0 0
From start of treatment up to death from any cause (up to approximately 3-5 years)
Secondary outcome [8] 0 0
Percentage of etrumadenant target inhibition in peripheral blood
Timepoint [8] 0 0
Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and at the end of treatment (in total approximately 5 months)
Secondary outcome [9] 0 0
Immunophenotyping activity in select immune subsets for etrumadenant and IPI-549 in peripheral blood
Timepoint [9] 0 0
Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and at the end of treatment (in total approximately 5 months).

Eligibility
Key inclusion criteria
* Female participants, 18 years or older
* Measurable disease per radiographic evaluation
* Performance status 0 or 1
* Available archival tissue sample (within 2 years) or a fresh tumor biopsy may be required
* Adequate organ, cardiac, and bone marrow function
* Dose escalation

* Participants with breast cancer:

* Locally advanced or metastatic triple negative breast cancer (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines) with disease progression
* No available alternative or curative therapy
* Participants may have received any number of prior therapies for advanced/recurrent and progressive disease
* Participants with ovarian cancer:

* Locally advanced or metastatic ovarian cancer with disease progression
* No available alternative or curative therapy
* Participants may have received any number of prior therapies for advanced/recurrent and progressive disease
* Dose expansion

* Participants with breast cancer:

* Locally advanced or metastatic triple negative breast cancer (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines)
* Disease progression after no more than 3 prior lines of therapy
* Participants with ovarian cancer:

* Locally advanced or metastatic ovarian cancer that is platinum-resistant
* Disease progression after no more than 3 prior lines of therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received a live, attenuated vaccine within 4 weeks prior to first study treatment
* Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy within 4 weeks prior first study treatment
* Cancer other than the disease under study within 2 years prior to study entry, except for some cancers with a low risk of spreading like non-melanoma skin cancers
* Inability to swallow oral medications
* Participant is breastfeeding, pregnant, or expects to become pregnant during the study
* Active autoimmune disease or documented history of autoimmune disease within 2 years prior to first study treatment
* History of peptic ulcer or stomach bleeding within 6 months prior to first study treatment
* Use of drugs contraindicated by the protocol within 4 weeks prior to and during study treatment
* Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment
* Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid - CSF (leptomeningeal disease)
* HIV, Hepatitis B, and C test results negative prior to first study treatment
* Major surgery within 4 weeks prior to first study treatment
* Participants who have previously received maximum cumulative lifetime anthracycline dosage or baseline ejection fraction <50% (on heart echography)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/07/2021
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
The Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [3] 0 0
St. George Private Hospital - Kogarah
Recruitment hospital [4] 0 0
Macquarie University - Macquarie
Recruitment hospital [5] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [6] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [7] 0 0
Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2109 - Macquarie
Recruitment postcode(s) [5] 0 0
4217 - Benowa
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arcus Biosciences, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Infinity Pharmaceuticals, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Arcus Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

For more information, please visit our website.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://trials.arcusbio.com/our-transparency-policy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03719326