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A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC. (AARDVARC)

Primary Purpose

Progressive Metastatic Castrate-Resistant Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AZD4635

Durvalumab

Cabazitaxel

About this trial

This is an interventional treatment trial for Progressive Metastatic Castrate-Resistant Prostate Cancer focused on measuring Prostate Cancer

Eligibility Criteria

18 Years - 150 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate.
Known castrate-resistant disease.
Evidence of disease progression ≤6 months.
Body weight >30 kg at screening.
Willingness to adhere to the study treatment-specific contraception requirements.
Adequate bone marrow reserve and organ function.
Adequate organ function for Arm A as demonstrated by all of the following laboratory values:
- Alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases.
- Aspartate aminotransferase (AST) ≤2.5 × ULN if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases
- Total bilirubin (TBL) ≤1.5 × ULN
- TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
Participants in Arm A must have received the following prior therapy:
- Maximum of 3 lines of therapy in the mCRPC setting
- Prior therapy with one or more NHAs (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) in either hormone-sensitive or hormone-refractory settings
- Prior therapy with one or more lines of taxanes (eg, docetaxel and/or cabazitaxel)
- Alternatively, must be taxane-ineligible
- Prior therapy can be in either the hormone-sensitive or the hormone-refractory setting
Adequate organ function for Arm B as demonstrated by all of the following laboratory values:
- AST and/or ALT ≤1.5 × ULN
- TBL ≤ ULN
- TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
Participants in Arm B must have received the following prior therapy:
- Prior docetaxel (taxane) in either hormone-sensitive or hormone-refractory settings
- Received no prior cytotoxic chemotherapy other than docetaxel for prostate cancer except for estramustine and except adjuvant/neo-adjuvant treatment completed >3 years ago.
- Prior therapy with only one NHAs (eg, abiraterone acetate or enzalutamide; prior apalutamide is not permitted) for treatment of mCRPC in either hormone-sensitive or hormone-refractory settings.
- Be suitable to receive concomitant Granulocyte-colony stimulating factor during all cycles of cabazitaxel.
- Participants who meet inclusion criteria for Arm B will be allocated preferentially to that arm until recruitment to that arm is completed.

Exclusion Criteria:

Active brain metastases or leptomeningeal metastases.
There must be no requirement for immunosuppressive doses of systemic corticosteroids for at least 2 weeks prior to study enrollment.
History of pneumonitis requiring corticosteroids, second malignancy that is progressing and/or received active treatment ≤3 years before the first dose of study intervention, and hypersensitivity to polysorbate-80 if allocated to cabazitaxel.
As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases.
Creatinine clearance <40 mL/min (calculated by Cockcroft-Gault equation).
Prior exposure to immune-mediated therapy including.
Ongoing treatment with warfarin (Coumadin).
Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study intervention.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A: AZD4635 + durvalumab

Arm B: AZD4635 + durvalumab + cabazitaxel

Arm Description

AZD4635 plus durvalumab (Arm A) will consist of participants with mCRPC previously treated with one or more approved NHAs (eg, abiraterone acetate, enzalutamide, apalutamide and/or darolutamide), and one or more taxanes, or participants who are taxane ineligible.

AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of participants with mCRPC previously treated with docetaxel and one prior NHA (either abiraterone acetate or enzalutamide but not both (prior apalutamide is not allowed in Arm B).

Outcomes

Primary Outcome Measures

Radiographic Progression Free Survival (rPFS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)

rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 (Prostate Cancer Working Group 3) criteria [bone] or death from any cause, whichever occurred first.

Secondary Outcome Measures

rPFS by Adenosine (ADO) Signalling Gene Expression in High and Low Subgroups to Determine the Efficacy of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC

rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 criteria (bone) or death from any cause, whichever occurred first.

Overall Survival (OS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC

OS was defined as the time from first dose until death due to any cause regardless of whether the participant withdrew from study treatment or received another anti-cancer therapy.

Number of Participants With Objective Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel

Confirmed ORR was defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) using overall radiographic response assessed by RECIST v1.1 and PCWG-3 criteria (bone), and was based on a subset of all treated participants with measurable disease at baseline per the site Investigator.

Number of Participants With Prostate-specifin Antigen (PSA50) Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel

Confirmed PSA50 response is defined as the proportion of participants who achieved a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA, confirmed by a consecutive PSA at least 3 weeks later and was based on PSA evaluable participants (dosed participants with an abnormal baseline PSA [≥1 ng/mL]).

Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)

"Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.

Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)

Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)

Number of Participants Who Progressed Based on BPI-SF Item 3

Pain progression was assessed using BPI-SF.

Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P

The Functional Assessment of Cancer Therapy-Prostate (FACT-P) will be used to measure health related quality of life (HRQL) in men with prostate cancer. It consists of 4 subscales (physical, emotional, functional and social/family well-being) plus a 12-item prostate-specific module, the PCS subscale, which highlights concerns specific to participants with prostate cancer. FAPSI-6 is defined as a symptom score made up of 6 items from within the FACT-P (pain [n = 3], fatigue [n = 1], weight loss [n = 1], and concerns about the condition getting worse [n = 1]). Each question in the FACT-P questionnaires has a choice of 5 responses, "Not at all", "A little bit", "Somewhat", "Quite a bit" and "Very much". The scores range from 0 ("Not at all") to 4 ("Very much") for positively phrased questions. Negatively phrased questions have a reverse scoring, from 0 ("Very much") to 4 ("Not at all"). This results in a consistent approach, where higher scores indicate a better quality of life.

Maximum Observed Plasma Concentration (Cmax)

Investigate the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Terminal Half-life (t1/2λz)

Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Area Under the Plasma Concentration Time Curve From Zero to the Time of the Last Measurable Concentration (AUClast)

Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Area Under the Plasma Concentration Time Curve From Zero to 24 Hours [AUC(0-24)]

Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Area Under the Plasma Concentration Time Curve From Zero Extrapolated to Infinity (AUCinf)

Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Apparent Volume of Distribution During the Terminal Phase (Vz/F)

Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Number of Subjects With Serious and Non-serious Adverse Events

Safety and tolerability of each treatment regimen were assessed in participants with mCRPC.

Full Information

NCT ID

NCT04495179

First Posted

July 23, 2020

Last Updated

July 21, 2023

Sponsor

AstraZeneca

Collaborators

Parexel

1. Study Identification

Unique Protocol Identification Number

NCT04495179

Brief Title

A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.

Acronym

AARDVARC

Official Title

A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination With Durvalumab and in Combination With Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 4, 2020 (Actual)

Primary Completion Date

November 1, 2021 (Actual)

Study Completion Date

August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Parexel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).

Detailed Description

This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with mCRPC. Participants in each arm will be stratified by the presence of measurable soft tissue metastasis (per Response Evaluation Criteria in Solid Tumours [RECIST v1.1]) or bone-only metastasis (per Prostate Cancer Working Group 3 [PCWG3 criteria]). There will be no formal comparisons between treatment arms. AZD4635 plus durvalumab (Arm A) will consist of 80 participants with mCRPC previously treated with one or more approved new hormonal agent(s) (NHAs) and one or more taxanes or participants who are taxane ineligible. AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of 80 participants mCRPC previously treated with docetaxel and one prior NHA. As of November 2020, the Sponsor stopped enrolment in Arm A following decisions at the program level, not related to any safety issues. Ongoing participants in Arm A may continue treatment as planned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Progressive Metastatic Castrate-Resistant Prostate Cancer

Keywords

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: AZD4635 + durvalumab

Arm Type

Experimental

Arm Description

Arm Title

Arm B: AZD4635 + durvalumab + cabazitaxel

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

AZD4635

Intervention Description

Subjects will receive AZD4635 orally daily

Intervention Type

Drug

Intervention Name(s)

Durvalumab

Intervention Description

Subjects will receive intravenous durvalumab every 4 weeks for Arm A and every 3 weeks for Arm B.

Intervention Type

Drug

Intervention Name(s)

Cabazitaxel

Intervention Description

Subjects will receive intravenous cabazitaxel every 3 weeks

Primary Outcome Measure Information:

Title

Description

Time Frame

From first dose to first documented progression or death from any cause (whichever comes first) (approximately 1 year)

Secondary Outcome Measure Information:

Title

rPFS by Adenosine (ADO) Signalling Gene Expression in High and Low Subgroups to Determine the Efficacy of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC

Description

Time Frame

From first dose to first documented progression or death from any cause (whichever comes first), up to two years

Title

Overall Survival (OS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC

Description

OS was defined as the time from first dose until death due to any cause regardless of whether the participant withdrew from study treatment or received another anti-cancer therapy.

Time Frame

Arm A and B: Every 90 days from the last dose of study drug up to 2 years

Title

Number of Participants With Objective Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel

Description

Time Frame

From first dose to first documented progression or death from any cause (whichever comes first), up to two years

Title

Number of Participants With Prostate-specifin Antigen (PSA50) Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel

Description

Time Frame

Arm A: Screening, Day 1 of each cycle up to 11 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 11 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

Title

Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)

Description

Time Frame

Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

Title

Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)

Description

Time Frame

Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

Title

Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)

Description

Time Frame

Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

Title

Number of Participants Who Progressed Based on BPI-SF Item 3

Description

Pain progression was assessed using BPI-SF.

Time Frame

Arm A: Screening, Day 1 of each cycle up to 12 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 12 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

Title

Description

Time Frame

Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

Title

Maximum Observed Plasma Concentration (Cmax)

Description

Investigate the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Time Frame

Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

Title

Terminal Half-life (t1/2λz)

Description

Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Time Frame

Title

Area Under the Plasma Concentration Time Curve From Zero to the Time of the Last Measurable Concentration (AUClast)

Description

Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Time Frame

Title

Area Under the Plasma Concentration Time Curve From Zero to 24 Hours [AUC(0-24)]

Description

Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Time Frame

Title

Area Under the Plasma Concentration Time Curve From Zero Extrapolated to Infinity (AUCinf)

Description

Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Time Frame

Title

Apparent Volume of Distribution During the Terminal Phase (Vz/F)

Description

Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Time Frame

Title

Number of Subjects With Serious and Non-serious Adverse Events

Description

Safety and tolerability of each treatment regimen were assessed in participants with mCRPC.

Time Frame

Arm A: From Screening up to 14 months (Each cycle was 28 days in length); Arm B: From Screening up to 14 months (Cycle 1 to Cycle 10 was 21 days in length, and Cycle 11 onwards was 28 days in length)

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

150 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate. Known castrate-resistant disease. Evidence of disease progression ≤6 months. Body weight >30 kg at screening. Willingness to adhere to the study treatment-specific contraception requirements. Adequate bone marrow reserve and organ function. Adequate organ function for Arm A as demonstrated by all of the following laboratory values: Alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases. Aspartate aminotransferase (AST) ≤2.5 × ULN if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases Total bilirubin (TBL) ≤1.5 × ULN TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin Participants in Arm A must have received the following prior therapy: Maximum of 3 lines of therapy in the mCRPC setting Prior therapy with one or more NHAs (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) in either hormone-sensitive or hormone-refractory settings Prior therapy with one or more lines of taxanes (eg, docetaxel and/or cabazitaxel) Alternatively, must be taxane-ineligible Prior therapy can be in either the hormone-sensitive or the hormone-refractory setting Adequate organ function for Arm B as demonstrated by all of the following laboratory values: AST and/or ALT ≤1.5 × ULN TBL ≤ ULN TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin Participants in Arm B must have received the following prior therapy: Prior docetaxel (taxane) in either hormone-sensitive or hormone-refractory settings Received no prior cytotoxic chemotherapy other than docetaxel for prostate cancer except for estramustine and except adjuvant/neo-adjuvant treatment completed >3 years ago. Prior therapy with only one NHAs (eg, abiraterone acetate or enzalutamide; prior apalutamide is not permitted) for treatment of mCRPC in either hormone-sensitive or hormone-refractory settings. Be suitable to receive concomitant Granulocyte-colony stimulating factor during all cycles of cabazitaxel. Participants who meet inclusion criteria for Arm B will be allocated preferentially to that arm until recruitment to that arm is completed. Exclusion Criteria: Active brain metastases or leptomeningeal metastases. There must be no requirement for immunosuppressive doses of systemic corticosteroids for at least 2 weeks prior to study enrollment. History of pneumonitis requiring corticosteroids, second malignancy that is progressing and/or received active treatment ≤3 years before the first dose of study intervention, and hypersensitivity to polysorbate-80 if allocated to cabazitaxel. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases. Creatinine clearance <40 mL/min (calculated by Cockcroft-Gault equation). Prior exposure to immune-mediated therapy including. Ongoing treatment with warfarin (Coumadin). Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study intervention.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher J Sweeney, MBBS

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Research Site

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Research Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Research Site

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Research Site

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Facility Name

Research Site

City

Hospitalet deLlobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

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URL

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Learn more about this trial

A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.

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A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC. (AARDVARC)

Progressive Metastatic Castrate-Resistant Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial