MelanomaPhase 3NCT00257205

CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

A Phase 3 study testing dacarbazine, CP-675,206 and temozolomide in people with Melanoma, run by AstraZeneca at 143 sites in 21 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma
What is being tested?: dacarbazine, CP-675,206 and temozolomide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 655 participants
Where: 143 sitesin 21 countries
Study dates: Mar 2006to Aug 2010
Phase: Phase 3
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
Serum lactic acid dehydrogenase (LDH) <= 2 x ULN
ECOG performance status of 0 or 1

Who cannot join

Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
History of brain metastases

Trial locations and contacts

143 sites in 21 countries.

Country

City, postcode or hospital

143 sites in 21 countries

United States55 sites

Research Site
Albany, New York, 12206
Research Site
Aurora, Colorado, 80045
Research Site
Bakersfield, California, 93309
Research Site
Baltimore, Maryland, 21237-3998
Research Site
Beech Grove, Indiana, 46107
Research Site
Bethlehem, Pennsylvania, 18015
Research Site
Boynton Beach, Florida, 33426
Research Site
Canton, Ohio, 44718
Research Site
Chapel Hill, North Carolina, 27599-7600
Research Site
Charlotte, North Carolina, 28203
Research Site
Charlotte, North Carolina, 28204
Research Site
City of Saint Peters, Missouri, 63376
Research Site
Columbus, Ohio, 43210
Research Site
Corona, California, 92879
Research Site
Creve Coeur, Missouri, 63141
Research Site
Dallas, Texas, 75246
Research Site
Dover, Ohio, 44718
Research Site
Federal Way, Washington, 98003
Research Site
Fullerton, California, 92835
Research Site
Glendora, California, 91741
Research Site
Henderson, Nevada, 89015
Research Site
Henderson, Nevada, 89052
Research Site
Huntington Beach, California, 92648
Research Site
Huntsville, Alabama, 35805
Research Site
Indianapolis, Indiana, 46237
Research Site
Indianapolis, Indiana, 46260
Research Site
Lake Worth, Florida, 33461-4710
Research Site
Lakewood, Washington, 98499
Research Site
Las Vegas, Nevada, 89109
Research Site
Las Vegas, Nevada, 89128
Research Site
Las Vegas, Nevada, 89135
Research Site
Las Vegas, Nevada, 89148
Research Site
Little Rock, Arkansas, 72205
Research Site
Long Beach, California, 90813
Research Site
Los Alamitos, California, 90720
Research Site
Los Angeles, California, 90095-6970
Research Site
Los Angeles, California, 90095
Research Site
Mobile, Alabama, 36607
Research Site
Morristown, New Jersey, 07962
Research Site
New York, New York, 10016
Research Site
Omaha, Nebraska, 68114
Research Site
Oxnard, California, 93030
Research Site
Pasadena, California, 91105
Research Site
Pittsburgh, Pennsylvania, 15232
Research Site
Pomona, California, 91767
Research Site
Rancho Cucamonga, California, 91730
Research Site
Salt Lake City, Utah, 84112
Research Site
Santa Barbara, California, 93105
Research Site
Santa Maria, California, 93454
Research Site
Scottsdale, Arizona, 85260
Research Site
St Louis, Missouri, 63110
Research Site
Stamford, Connecticut, 06902-3628
Research Site
Tacoma, Washington, 98405
Research Site
West Covina, California, 91790
Research Site
Zion, Illinois, 60099

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Canada13 sites

Research Site
Calgary, Alberta, T2N 4N2
Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
Hamilton, Ontario, L8V 5C2
Research Site
London, Ontario, N6A 4L6
Research Site
Montreal, Quebec, H2L 4M1
Research Site
Québec, Quebec, G1R 2J6
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 2M9
Research Site
Vancouver, British Columbia, V5Z 4E6
Research Site
Victoria, British Columbia, V8R 6V5
Research Site
Windsor, Ontario, N8W 1L9
Research Site
Windsor, Ontario, N8W 2X3
Research Site
Winnipeg, Manitoba, R3E 0V9

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France9 sites

Research Site
Besançon, 25030
Research Site
Bordeaux, 33075
Research Site
Boulogne, 92104
Research Site
Caen, 14033
Research Site
Lille, 59000
Research Site
Marseille, 13009
Research Site
Montpellier, Cedex 05, 34280
Research Site
Nantes, 44035
Research Site
Paris, 75010

Other trials in France

Spain8 sites

Research Site
Barcelona, Barcelona, 08036
Research Site
L'Hospitalet de Llobregat, Barcelona, 08907
Research Site
Madrid, Madrid, 28041
Research Site
Oviedo, Principality of Asturias, 33006
Research Site
Palma de Mallorca, Balearic Islands, 07014
Research Site
Pamplona, Navarre, 31008
Research Site
Santander, Cantabria, 39008
Research Site
Zaragoza, Zaragoza, 50009

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United Kingdom8 sites

Research Site
London, SW3 6JJ
Research Site
Manchester, M20 4BX
Research Site
Newcastle upon Tyne, NE4 6BE
Research Site
Newcastle upon Tyne, NE7 7DN
Research Site
Northwood, Middlesex, HA6 2RN
Research Site
Sutton, Surrey, SM2 5PT
Research Site
Truro, Cornwall, TR1 3LJ
Research Site
Wolverhampton, WV10 0QP

Other trials in United Kingdom

Belgium7 sites

Research Site
Brussels, 1090
Research Site
Leuven, 3000
Research Site
Namur, 5000
Research Site
Roeselare, 8800
Research Site
Turnhout, 2300
Research Site
Wilrijk, 2610
Research Site
Yvoir, 5530

Other trials in Belgium

Australia6 sites

Research Site
Adelaide, South Australia, 5000
Research Site
East Melbourne, Victoria, 3002
Research Site
Launceston, Tasmania, 7250
Research Site
Waratah, New South Wales, 2300
Research Site
Westmead, New South Wales, 2145
Research Site
Woolloongabba, Queensland, 4102

Other trials in Australia

Italy6 sites

Research Site
Genova, 16132
Research Site
Milan, 20141
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Roma, 00144
Research Site
Siena, 53100

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Germany5 sites

Research Site
Berlin, 10117
Research Site
Frankfurt, 60488
Research Site
Hanover, 30449
Research Site
Kiel, 24105
Research Site
Tübingen, 72076

Other trials in Germany

Poland5 sites

Research Site
Bialystok, 15-027
Research Site
Krakow, 31-115
Research Site
Lubin, 59-300
Research Site
Poznan, 61-866
Research Site
Warsaw, 02-781

Other trials in Poland

Netherlands4 sites

Research Site
Amsterdam, North Holland, 1066 CX
Research Site
Groningen, Provincie Groningen, 9713 GZ
Research Site
Leiden, South Holland, 2311 JS
Research Site
Nijmegen, 6525 GA

Other trials in Netherlands

Israel3 sites

Research Site
Jerusalem, 91120
Research Site
Tel Aviv, 64239
Research Site
Tel HaShomer, 52621

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Russia3 sites

Research Site
Moscow, 115478
Research Site
Obninsk, Kaluga Oblast, 249036
Research Site
Saint Petersburg, 197758

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Mexico2 sites

Research Site
Mexico City, Mexico City, 06720
Research Site
Mexico City, Mexico City, 14080

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South Africa2 sites

Research Site
Cape Town, 7500
Research Site
Pretoria, 0181

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Sweden2 sites

Research Site
Gothenburg, 413 45
Research Site
Lund, 221 85

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Argentina1 site

Research Site
Ciudad de Buenos Aires, Buenos Aires, C1280AEA

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Austria1 site

Research Site
Vienna, A-1090

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Greece1 site

Research Site
Athens, 115 27

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Slovakia1 site

Research Site
Bratislava, 833 10

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Switzerland1 site

Research Site
Zurich, 8091

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About this study

Official title: A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma

This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

Conditions: Melanoma
Being tested: dacarbazine, CP-675,206, temozolomide
Medical subject headings: Melanoma

What participants receive

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

dacarbazineDrug
decarbazine 1000 mg/m2 IV Q 21 days x 12
CP-675,206Drug
Also called anti-CTLA4 human monoclonal antibody
CP-675,206 15 mg/kg IV Q 90 days x 4
temozolomideDrug
temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12

Study groups in NCT00257205
Study group	Role	What they receive
B	Active comparator	Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice) Receives: Drug: dacarbazine; Drug: temozolomide
A	Experimental	Not described Receives: Drug: CP-675,206

What is being measured

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

overall survival
Measured: August 2010

Secondary outcomes (9)

adverse events
Measured: 1 year
PFS at 6 months
Measured: 6 months
objective tumor response
Measured: 1 year
Durable response
Measured: 6 months
pharmacokinetics endpoints
Measured: 15 months
pharmacogenomic endpoints
Measured: 1 year
HQol
Measured: 1 year
healthcare resource utilization and loss of productivity
Measured: 1 year
human antihuman antibody response for patients in Arm A
Measured: 15 months

Timeline

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

Mar 2006Aug 2010

First posted22 Nov 2005 (estimated)
Study startMar 2006
Primary completionAug 2010
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MelanomaStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 655 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00257205
Sponsor's protocol ID: A3671009
Status last verified: Jun 2012
First submitted: 18 Nov 2005
Last updated: 2 Jul 2012
Results posted: No
Data monitoring committee: Yes

Publications

Friedlander P, Wood K, Wassmann K, Christenfeld AM, Bhardwaj N, Oh WK. A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab. J Immunother Cancer. 2018 Sep 18;6(1):90. doi: 10.1186/s40425-018-0408-9.
PubMed 30227886
Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hauschild A. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013 Feb 10;31(5):616-22. doi: 10.1200/JCO.2012.44.6112. Epub 2013 Jan 7.
PubMed 23295794

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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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
ClinicalTrials.gov ID: NCT00257205
Acronym / sponsor ID: A3671009
Conditions: Melanoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 655 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 22 Nov 2005 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
B	Active comparator	Drug: dacarbazine, Drug: temozolomideChoice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
A	Experimental	Drug: CP-675,206

Who may qualify

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

Key inclusion criteria (3 listed)

Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
Serum lactic acid dehydrogenase (LDH) <= 2 x ULN
ECOG performance status of 0 or 1

Key exclusion criteria (2 listed)

Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
History of brain metastases

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
dacarbazinedecarbazine 1000 mg/m2 IV Q 21 days x 12	Drug	B
CP-675,206Also: anti-CTLA4 human monoclonal antibodyCP-675,206 15 mg/kg IV Q 90 days x 4	Drug	A
temozolomidetemozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12	Drug	B

Primary outcome

overall survival
Time frame: August 2010

9 secondary outcomes

adverse events
Time frame: 1 year
PFS at 6 months
Time frame: 6 months
objective tumor response
Time frame: 1 year
Durable response
Time frame: 6 months
pharmacokinetics endpoints
Time frame: 15 months
pharmacogenomic endpoints
Time frame: 1 year
HQol
Time frame: 1 year
healthcare resource utilization and loss of productivity
Time frame: 1 year
human antihuman antibody response for patients in Arm A
Time frame: 15 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
Derived from this study: PubMed 30227886Friedlander P, Wood K, Wassmann K, Christenfeld AM, Bhardwaj N, Oh WK. A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab. J Immunother Cancer. 2018 Sep 18;6(1):90. doi: 10.1186/s40425-018-0408-9.
Derived from this study: PubMed 23295794Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hauschild A. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013 Feb 10;31(5):616-22. doi: 10.1200/JCO.2012.44.6112. Epub 2013 Jan 7.

Related trials for Melanoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

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.

The record lists no contact. Use the official record to reach the sponsor.

143 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dacarbazine, CP-675,206 and temozolomide in people with Melanoma, run by AstraZeneca at 143 sites in 21 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 2 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 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, Canada, France, Spain, United Kingdom and 16 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

overall survival (time frame: August 2010). 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 NCT00257205, which also lists 2 linked publications.

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 2 Jul 2012.