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CP-675, 206

Phase 3

Melanoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 22, 2024

Success Probability

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials2
Total Enrollment740

FDA Designations

No designations recorded

Clinical trial landscape

CP-675, 206 · 8 trials · 10 indications

Phase 3 1Phase 2 5Phase 1 2
NCT00257205CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior TherapyMelanoma
COMPLETED655 Analytics
PHASE3COMPLETED
CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

overall survival
August 2010
Safety Endpoints: Serious Adverse Events to Tremelimumab.
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.
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.
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)
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
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 length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care.
3 months to 2 years from randomization
To assess the best overall response rate per RECIST (BRR) in patients with metastatic adenocarcinoma of the colon or rectum treated with CP-675,206 .
18 months
To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma
Tumor response is assessed every 2-3 months until disease progression
Safety
At every scheduled visit for a maximum of 2 years from first dose of study drug
Tumor response
Assessed every 2-3 months up to 2 years from first dose of study drug
To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug
6 weeks after first dose
Pharmacokinetics: maximum plasma concentration of CP-675,206
1 hour
Pharmacokinetics: AUC, defined as the area under the concentration -time curve
Time 0 to Day 85

Secondary Endpoints

adverse events
1 year
PFS at 6 months
6 months
objective tumor response
1 year
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BACTIVE_COMPARATORChoice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
AEXPERIMENTAL -
1EXPERIMENTALDrug: CP-675,206 (Tremelimumab)
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
15 mg/kg CP-675,206EXPERIMENTAL -
10 mg/kgEXPERIMENTALpts treated at 10 mg/kg dose level on a monthly regimen
15 mg/kgEXPERIMENTALpts treated at 15 mg/kg dose level on a quarterly regimen
Commercial FormulationEXPERIMENTALCommercial Formulation
Current FormulationEXPERIMENTALCurrent Formulation

Interventions

NameTypeDescription
dacarbazineDRUGdecarbazine 1000 mg/m2 IV Q 21 days x 12
CP-675,206DRUGCP-675,206 15 mg/kg IV Q 90 days x 4
temozolomideDRUGtemozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
CP-675,206 (Tremelimumab)DRUG15 mg/kg IV every 3 months as long as required
best supportive careDRUGAs per investigator discretion. Excludes chemotherapy or other anti-cancer therapy
SU011248DRUGSU011248 administered at a dose of 37.5mg/day every day.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites143

Inclusion Criteria: * 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 Exclusion Criteria: * Received any systemic therapy for...

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaFranceGermanyGreeceIsraelItalyMexicoNetherlandsPolandRussiaSlovakiaSouth AfricaSpainSwedenSwitzerlandUnited KingdomCzechiaSouth Korea
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Frequently asked questions about CP-675, 206

What is CP-675,206 used for?

CP-675,206 is an investigational oncology therapy being studied in prostatic neoplasms, melanoma, pancreatic cancer, renal cell carcinoma, non-small-cell lung cancer, and colorectal neoplasms. It is a small molecule being developed by AstraZeneca PLC and is currently in Phase 2 clinical development.

What does CP-675,206 target?

CP-675,206 is a small molecule oncology therapy. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated across multiple solid tumor types including melanoma, renal cell carcinoma, and non-small-cell lung cancer.

Who makes CP-675,206?

CP-675,206 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 2 clinical trials for multiple oncology indications.

What phase is CP-675,206 in?

CP-675,206 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, along with two Phase 1 trials, with a total enrollment of 740 patients across all studies.

What clinical trials is CP-675,206 in?

CP-675,206 has completed two Phase 2 trials: NCT00086489 in advanced melanoma and NCT00312975 in non-small-cell lung cancer. Two Phase 1 trials, NCT00372853 in metastatic renal cell carcinoma and NCT00431275 in melanoma, have also been completed. All trials are closed.

Is CP-675,206 the same as tremelimumab?

CP-675,206 is an investigational monoclonal antibody being developed by AstraZeneca. While it has been studied in oncology indications, no alternative names have been established in the clinical trial records. The drug remains in Phase 2 development.