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CP-675, 206

Phase 3

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

Target and mechanism

ModalitySmall molecule

Also known as CP-675,206 (Tremelimumab)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials2
Total Enrollment740

FDA Designations

No designations recorded

Clinical trial landscape

CP-675, 206 · 10 trials · 11 indications

Phase 3 1Phase 2 5Phase 1 4
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
Dose Limiting Toxicities: assessed through adverse event data collected weekly
8 week intervals
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
Assess safety of combination therapy and effectiveness as assessed by pathological response after 3 months of treatment follow for disease status for a maximum of 24 months

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
CP-675,206 and gemcitabineEXPERIMENTAL -
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
CP-675,206 and gemcitabineDRUGEscalating doses of CP-675,206 will be administered by IV infusion on day 1 of each 84-day treatment cycles (doses of 6, 10 and 15 mg/kg are planned). Gemcitabine will be administered by IV infusion, at a fixed dose of 1000 mg/m2 on days 1 (prior to CP-675,206) and again on days 8, 15, 29, 36, 43, 57, 64, and 71. Repeated cycles of gemcitabine and CP-675,206 will be administered until patients develop progressive disease or unacceptable toxicity, or for a maximum of 4 cycles, whichever occurs first.
SU011248DRUGSU011248 administered at a dose of 37.5mg/day every day.
CP-675,206 and leuprolide acetate and bicalutamideDRUG -
leuprolide acetate and bicalutamideDRUG -
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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?

CP-675,206 is an investigational oncology drug also known as tremelimumab. It is being developed by AstraZeneca PLC (ticker AZN) and has been studied in cancers including non-small-cell lung carcinoma, renal cell carcinoma, colorectal neoplasms, melanoma, and pancreatic cancer. It is in Phase 2 development.

What is CP-675,206 used for?

CP-675,206 has been studied in several cancer types, including non-small-cell lung carcinoma, renal cell carcinoma, colorectal neoplasms, malignant melanoma, melanoma, and pancreatic cancer. It remains an investigational agent in Phase 2 development and is not described as approved for any indication.

Who is developing CP-675,206?

AstraZeneca PLC, which trades under the ticker AZN, is the developer of CP-675,206. The company has sponsored clinical studies of the agent in pancreatic cancer, melanoma, renal cell carcinoma, and other tumor types.

What phase is CP-675,206 in?

CP-675,206 is in Phase 2 development. The program includes completed Phase 1 and Phase 2 studies, and no active trials are currently listed. It is an investigational agent and is not described as FDA approved.

What clinical trials is CP-675,206 in?

Completed studies include NCT00556023, a Phase 1 trial of CP-675,206 with gemcitabine in advanced pancreatic cancer; NCT00431275, a Phase 1 comparison of two CP-675,206 formulations in melanoma; NCT00378482, a Phase 2 rollover study; and NCT00372853, a Phase 1 dose-finding study in metastatic renal cell carcinoma.

Is CP-675,206 the same as tremelimumab?

Yes, CP-675,206 is also known as tremelimumab. The names refer to the same agent, and combination regimens studied with it include CP-675,206 and gemcitabine, as well as CP-675,206 with leuprolide acetate and bicalutamide.