Carcinoma, MelanomaPhase 2NCT00070642
CPG 7909 Injection in Melanoma
A Phase 2 study testing CPG 7909 Injection, dacarbazine and Chemotherapy in people with Carcinoma, Melanoma, run by Pfizer.
Trial summary
To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Melanoma
- What is being tested?
- CPG 7909 Injection, dacarbazine and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Dec 2005
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed melanoma that is metastatic.
- Measurable disease according to the RECIST criteria.
- Karnofsky Performance Status of > 70.
Who cannot join
- Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy other than DTIC).
- Suspected or known CNS metastases.
About this study
Official title: ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study
To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.
- Conditions
- Carcinoma, Melanoma
- Being tested
- CPG 7909 Injection, dacarbazine, Chemotherapy
- Keywords
- Immunotherapy, skin cancer
- Medical subject headings
- Carcinoma, Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPG 7909 InjectionDrug
Also called ProMune, PF-3512676
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
dacarbazineDrug
Also called DTIC
dacarbazine 850mg/m2 in three-week cycles until disease progression
ChemotherapyDrug
Also called DTIC
Chemotherapy in three-week cycles until disease progression:
dacarbazine 850mg/m2
CPG 7909 InjectionDrug
Also called ProMune, PF-03512676
CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
CPG 7909 InjectionDrug
Also called ProMune, PF-03512676
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
| Study group | Role | What they receive |
|---|---|---|
| CPG 7909 Injection plus chemotherapy | Experimental | CPG 7909 Injection plus DTIC Receives: Drug: CPG 7909 Injection; Drug: dacarbazine |
| Chemotherapy alone | Active comparator | dacarbazine Receives: Drug: Chemotherapy |
| CPG 7909 Injection 10 mg | Experimental | Not described Receives: Drug: CPG 7909 Injection |
| CPG 7909 Injection 40 mg | Experimental | Not described Receives: Drug: CPG 7909 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.
Measured: indeterminate
Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.
Measured: Indeterminate
Secondary outcomes (6)
Phase III: Assess the overall response rate
Measured: indeterminate
Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.
Measured: indeterminate
Determine the duration of response.
Measured: indeterminate
Determine the time to progression
Measured: indeterminate
Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only).
Measured: indeterminate
Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone
Measured: indeterminate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2003 (estimated)
- Study startDec 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, MelanomaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070642
- Sponsor's protocol ID
- C023
- Other IDs
- CO23, A8501023
- Status last verified
- Feb 2009
- First submitted
- 6 Oct 2003
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study
- ClinicalTrials.gov ID
- NCT00070642
- Acronym / sponsor ID
- C023
- Conditions
- Carcinoma, Melanoma
- Keywords
- Immunotherapy, skin cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 8 Oct 2003 (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.
To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CPG 7909 Injection plus chemotherapy | Experimental | Drug: CPG 7909 Injection, Drug: dacarbazineCPG 7909 Injection plus DTIC |
| Chemotherapy alone | Active comparator | Drug: Chemotherapydacarbazine |
| CPG 7909 Injection 10 mg | Experimental | Drug: CPG 7909 Injection |
| CPG 7909 Injection 40 mg | Experimental | Drug: CPG 7909 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed melanoma that is metastatic.
- Measurable disease according to the RECIST criteria.
- Karnofsky Performance Status of > 70.
Key exclusion criteria (2 listed)
- Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy other than DTIC).
- Suspected or known CNS 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 |
|---|---|---|
| CPG 7909 InjectionAlso: ProMune, PF-3512676CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly. | Drug | CPG 7909 Injection plus chemotherapy |
| dacarbazineAlso: DTICdacarbazine 850mg/m2 in three-week cycles until disease progression | Drug | CPG 7909 Injection plus chemotherapy |
| ChemotherapyAlso: DTICChemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2 | Drug | Chemotherapy alone |
| CPG 7909 InjectionAlso: ProMune, PF-03512676CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly. | Drug | CPG 7909 Injection 10 mg |
| CPG 7909 InjectionAlso: ProMune, PF-03512676CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly. | Drug | CPG 7909 Injection 40 mg |
Primary outcome
Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.
Time frame: indeterminate
Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.
Time frame: Indeterminate
6 secondary outcomes
Phase III: Assess the overall response rate
Time frame: indeterminate
Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.
Time frame: indeterminate
Determine the duration of response.
Time frame: indeterminate
Determine the time to progression
Time frame: indeterminate
Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only).
Time frame: indeterminate
Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone
Time frame: indeterminate
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 10 Feb 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Carcinoma, Melanoma
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
Enrolling by invitationObservational study
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Melanoma, Adenocarcinoma
RecruitingPhase 1/2
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
Pancreatic Cancer, Renal Cell Cancer
Not yet recruitingPhase 1
SI-B036-ST-101 in Advanced/Metastatic Solid Tumors
Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors
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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPG 7909 Injection, dacarbazine and Chemotherapy in people with Carcinoma, Melanoma, run by Pfizer.
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 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria. (time frame: indeterminate). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2009.