MelanomaPhase 1NCT03159117
Pfizer PF-06688992 in Patients With Stage III or Stage IV Melanoma
A Phase 1 study testing PF-06688992 in people with Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this research study is to learn about the safety and effectiveness of the study drug, PF-06688992. Before this study, PF-06688992 has never been given to people. PF-06688992 is a targeted therapy for people with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- PF-06688992
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2017to 10 Jan 2020
- Phase
- Phase 1
- 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
- Histological diagnosis of melanoma confirmed at MSKCC
- Measurable unresectable Stage III or IV Malignant Melanoma and Response Criteria in Solid Tumors [RECIST], Version 1.1.
- Patients must have progressed on prior approved checkpoint inhibitor therapy, not tolerated approved checkpoint inhibitor therapy, or have a contraindication to approved checkpoint inhibitors. Patients with stable disease after approved checkpoint inhibitor therapy will also be eligible.
- Patients whose melanomas harbor a BRAF V600E or V600K mutation must have progressed on a RAF inhibitor. Patients who had to discontinue RAF inhibitor therapy because of toxicity but who did not progress will be eligible unless they responded to therapy. In that case, they will not be eligible unless they progress.
- Age ≥ 18 years
- ECOG performance status 0-1.
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- Adequate Bone Marrow Function as defined by:
- °≥1,500/mm^3 or ≥ 1.5 x 10^9/L;
- Platelets ≥ 100,000/mm3 or ≥ 100 x 109/L;
- Hemoglobin ≥ 9 g/dL.
- Adequate Renal Function as defined by:
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN); or
- Estimated creatinine clearance ≥ 60 mL/min as calculated using the method standard for the institution.
- Adequate Liver Function as defined by:
- Total serum bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome;
- Aspartate and Alanine Aminotransferase (AST \& ALT) ≤ 2.5 x ULN; ≤ 5.0 x ULN if there is liver involvement secondary to tumor;
- Alkaline phosphatase ≤ 2.5 x ULN; (≤ 5 x ULN in case of bone metastasis).
- QTc interval < 470 msec.
- Recovery from all prior surgical or adjuvant treatment-related toxicities, to Baseline status, or a CTCAE Grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia. Post-surgical pain will not be considered a basis for exclusion.
- Negative serum/urine pregnancy test (for women of childbearing potential).
- Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
- Evidence of a signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Who cannot join
- Patients with known symptomatic brain metastases requiring steroids.
- Patients with previously diagnosed brain metastases are eligible as long as they do not require CNS-directed therapy (including corticosteroids). If the patient has had radiation therapy or surgery, then they should have completed treatment and have discontinued corticosteroids for at least 2 weeks and must be neurologically stable.
- Patients with uveal melanoma will not be eligible as these tumors show low expression of GD3.
- Major surgery, radiation therapy or systemic anti-cancer therapy within 2 weeks of starting study treatment.
- Presence of ≥ Grade 2 peripheral neuropathy.
- Significant prior infusion reaction to monoclonal antibodies that required treatment with systemic steroids.
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- Active and clinically significant bacterial, fungal or viral infection.
- Known infections with hepatitis B (HBV) or hepatitis C (HCV),
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness not controlled (with undetectable viral load) on HAART therapy. Patients on HAART with undetectable viral loads may be eligible per PI judgment.
- Pregnant or breastfeeding; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
- Patients currently receiving active treatment for melanoma.
- Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack.
- Any ongoing cardiac dysrhythmias of NCI CTCAE Grade >2, NCI CTCAE Grade 4 atrial fibrillation, or QTcF interval >470 msec, except for documented Right Bundle Branch Block, at screening.
- Chronic Bronchitis or Emphysema requiring oxygen therapy within the last 6 months.
- Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality or uncontrolled hypertension that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase I Open-Label Dose Escalation of GD3 ADC (Pfizer PF-06688992) in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma (B802WI209568)
The purpose of this research study is to learn about the safety and effectiveness of the study drug, PF-06688992. Before this study, PF-06688992 has never been given to people.
PF-06688992 is a targeted therapy for people with cancer. The investigators linked a chemotherapy drug to an antibody (protein found in the blood). The antibody will connect to GD3 which is found on most melanomas but on very few other cells in the body. The investigators hope that in this way, it will deliver this chemotherapy directly to the melanoma and not to normal tissues.
- Conditions
- Melanoma
- Being tested
- PF-06688992
- Keywords
- GD3 ADC (Pfizer PF-06688992), Stage III Melanoma, Stage IV Melanoma, 17-165
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06688992Drug
Also called GD3 ADC
(PF-06688992) will be administered on Day 1 of each 21-day cycle per the Dose Preparation and Administration Instructions (DAI) located in the Investigational Product Manual (Appendix 4Appendix 3) as an IV infusion over approximately 60 minutes. A cycle is defined as the time from Day 1 dose to the next Day 1 dose. If there are no treatment delays, a cycle will be 21 days. Each patient may receive PF-06688992 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination
| Study group | Role | What they receive |
|---|---|---|
| PF 06688992 | Experimental | This clinical study will be a dose-finding phase I study in which patients will be treated with various doses of Pfizer PF-06688992 using a Bayesian dose escalation scheme. Receives: Drug: PF-06688992 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Recommended Phase 2 Dose
using a Bayesian dose escalation scheme
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start16 May 2017
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a Phase 1 non-randomized, open-label, single-center, single-arm multiple dose escalation
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Paul Chapman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159117
- Sponsor's protocol ID
- 17-165
- Status last verified
- Jan 2020
- First submitted
- 17 May 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label Dose Escalation of GD3 ADC (Pfizer PF-06688992) in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma (B802WI209568)
- ClinicalTrials.gov ID
- NCT03159117
- Acronym / sponsor ID
- 17-165
- Conditions
- Melanoma
- Keywords
- GD3 ADC (Pfizer PF-06688992), Stage III Melanoma, Stage IV Melanoma, 17-165
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 16 May 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 18 May 2017 (actual)
- 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.
The purpose of this research study is to learn about the safety and effectiveness of the study drug, PF-06688992. Before this study, PF-06688992 has never been given to people.
PF-06688992 is a targeted therapy for people with cancer. The investigators linked a chemotherapy drug to an antibody (protein found in the blood). The antibody will connect to GD3 which is found on most melanomas but on very few other cells in the body. The investigators hope that in this way, it will deliver this chemotherapy directly to the melanoma and not to normal tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Phase 1 non-randomized, open-label, single-center, single-arm multiple dose escalation
| Arm | Type | Receives |
|---|---|---|
| PF 06688992 | Experimental | Drug: PF-06688992This clinical study will be a dose-finding phase I study in which patients will be treated with various doses of Pfizer PF-06688992 using a Bayesian dose escalation scheme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histological diagnosis of melanoma confirmed at MSKCC
- Measurable unresectable Stage III or IV Malignant Melanoma and Response Criteria in Solid Tumors [RECIST], Version 1.1.
- Patients must have progressed on prior approved checkpoint inhibitor therapy, not tolerated approved checkpoint inhibitor therapy, or have a contraindication to approved checkpoint inhibitors. Patients with stable disease after approved checkpoint inhibitor therapy will also be eligible.
- Patients whose melanomas harbor a BRAF V600E or V600K mutation must have progressed on a RAF inhibitor. Patients who had to discontinue RAF inhibitor therapy because of toxicity but who did not progress will be eligible unless they responded to therapy. In that case, they will not be eligible unless they progress.
- Age ≥ 18 years
Key exclusion criteria (15 listed)
- Patients with known symptomatic brain metastases requiring steroids.
- Patients with previously diagnosed brain metastases are eligible as long as they do not require CNS-directed therapy (including corticosteroids). If the patient has had radiation therapy or surgery, then they should have completed treatment and have discontinued corticosteroids for at least 2 weeks and must be neurologically stable.
- Patients with uveal melanoma will not be eligible as these tumors show low expression of GD3.
- Major surgery, radiation therapy or systemic anti-cancer therapy within 2 weeks of starting study treatment.
- Presence of ≥ Grade 2 peripheral neuropathy.
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 |
|---|---|---|
| PF-06688992Also: GD3 ADC(PF-06688992) will be administered on Day 1 of each 21-day cycle per the Dose Preparation and Administration Instructions (DAI) located in the Investigational Product Manual (Appendix 4Appendix 3) as an IV infusion over approximately 60 minutes. A cycle is defined as the time from Day 1 dose to the next Day 1 dose. If there are no treatment delays, a cycle will be 21 days. Each patient may receive PF-06688992 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination | Drug | PF 06688992 |
Primary outcome
the Recommended Phase 2 Dose
Time frame: 1 year
using a Bayesian dose escalation scheme
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 22 Jan 2020.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Paul Chapman, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06688992 in people with Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 23 inclusion and 15 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 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
the Recommended Phase 2 Dose (time frame: 1 year). 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 22 Jan 2020.