Colorectal NeoplasmsPhase 2NCT00378482

A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.

A Phase 2 study testing CP-675,206 (Tremelimumab) in people with Colorectal Neoplasms and Melanoma, run by AstraZeneca at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Colorectal Neoplasms, Melanoma, Prostatic Neoplasms
What is being tested?: CP-675,206 (Tremelimumab)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 6 sitesin 2 countries
Study dates: 5 Mar 2007to 27 Oct 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject must have already received tremelimumab in another protocol
Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator.
Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures

Who cannot join

None

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States5 sites

Research Site
Ann Arbor, Michigan, 48109
Research Site
Houston, Texas, 77030
Research Site
Los Angeles, California, 90024
Research Site
New York, New York, 10016
Research Site
Tampa, Florida, 33612

Other trials in United States

United Kingdom1 site

Research Site
Newecastle Upon Tyne, NE7 7DN

Other trials in United Kingdom

About this study

Official title: A Rollover Protocol For Patients Who Received Tremelimumab (CP-675,206 ) In Other Protocols

This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.

Conditions: Colorectal Neoplasms, Melanoma, Prostatic Neoplasms, Renal Cell Carcinoma, Neoplasms, Patients Who Have/Have Had Melanoma and Other Tumors
Being tested: CP-675,206 (Tremelimumab)
Keywords: Melanoma and other tumors
Medical subject headings: Colorectal Neoplasms, Melanoma, Prostatic Neoplasms, Carcinoma, Renal Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CP-675,206 (Tremelimumab)Drug
Also called anti-CTLA4 human monoclonal antibody
15 mg/kg IV every 3 months as long as required

Study groups in NCT00378482
Study group	Role	What they receive
1	Experimental	Drug: CP-675,206 (Tremelimumab) Receives: Drug: CP-675,206 (Tremelimumab)

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Endpoints: Serious Adverse Events to Tremelimumab.
Measured: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
Measured: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
Measured: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
Measured: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Efficacy Endpoints: Survival
Measured: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.

Secondary outcomes (1)

Disease Free Survival
Time from the first dose of study drug to the earliest date of evidence of disease (based on tumor status assessment) or death, whichever occurred first
Measured: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 200727 Oct 2023

First posted20 Sep 2006 (estimated)
Study start5 Mar 2007
Primary completion27 Oct 2023
Study completion27 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00378482
Sponsor's protocol ID: D4881C00024
Other IDs: D4881C00024 (A3671024), 2008-000989-23, 2008
Status last verified: Aug 2024
First submitted: 19 Sep 2006
Last updated: 22 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Rollover Protocol For Patients Who Received Tremelimumab (CP-675,206 ) In Other Protocols
ClinicalTrials.gov ID: NCT00378482
Acronym / sponsor ID: D4881C00024
Conditions: Colorectal Neoplasms, Melanoma, Prostatic Neoplasms, Renal Cell Carcinoma, Neoplasms, Patients Who Have/Have Had Melanoma and Other Tumors
Keywords: Melanoma and other tumors
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 5 Mar 2007 (actual)
Primary completion: 27 Oct 2023 (actual)
Study completion: 27 Oct 2023 (actual)
First posted: 20 Sep 2006 (estimated)
Results: Posted 28 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: CP-675,206 (Tremelimumab)Drug: CP-675,206 (Tremelimumab)

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

The subject must have already received tremelimumab in another protocol
Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator.
Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CP-675,206 (Tremelimumab)Also: anti-CTLA4 human monoclonal antibody15 mg/kg IV every 3 months as long as required	Drug	1

Primary outcome

Safety Endpoints: Serious Adverse Events to Tremelimumab.
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Efficacy Endpoints: Survival
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.

1 secondary outcome

Disease Free Survival
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.

Results and safety

Results posted to the registry on 28 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tremelimumab 15mg/kg	37	6

Primary outcome: Safety Endpoints: Serious Adverse Events to Tremelimumab.

Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.. Count of participants. Unit: Participants

Measure	Tremelimumab 15mg/kg n = 37
Number of Participants with SAE to tremelimumab	4
Number of Participants with no SAE to tremelimumab	33

Population analysed: 37 Participants received study treatment

Primary outcome: Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.

Measure	Tremelimumab 15mg/kg n = 37
Number of participants with Grade 3 or 4 tremelimumab-related adverse events to tremelimumab	4
Number of participants with no Grade 3 or 4 tremelimumab-related adverse events to tremelimumab	33

Population analysed: 37 Participants received study treatment

Primary outcome: Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.

Measure	Tremelimumab 15mg/kg n = 37
Number of participants with Hypersensitivity reactions to tremelimumab	6
Number of participants with no Hypersensitivity reactions to tremelimumab	31

Population analysed: 37 Participants received study treatment

Primary outcome: Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)

Measure	Tremelimumab 15mg/kg n = 37
No evidence of disease	19
Evidence of disease	17
Indeterminate	1

Population analysed: Treated patients with response assessed

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 13 years, 3 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tremelimumab 15mg/kg	4 of 37 (10.8%)	5 of 37 (13.5%)	11 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Redacted SAPLink provided by the sponsor.
Redacted CSPLink provided by the sponsor.
CSR SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

Related trials for Colorectal Neoplasms

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
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Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca AstraZeneca study director

AstraZeneca

Peter Langmuir, Dir.Medic.Science study director

AstraZeneca

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP-675,206 (Tremelimumab) in people with Colorectal Neoplasms and Melanoma, run by AstraZeneca at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Endpoints: Serious Adverse Events to Tremelimumab. (time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00378482.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.