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New treatment option for Metastatic Malignant Neoplasm to Brain
Official title Palbociclib and Pembrolizumab In Central Nervous System Metastases
ClinicalTrials.gov ID: NCT02896335
What this study is testing
What is Palbociclib?
Palbociclib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic malignant neoplasm to brain.
Also referred to as Ibrance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research study is studying This research study is studying the efficacy and safety of the following study drugs as a possible treatment for recurrent central nervous system (CNS) metastases: Palbociclib alone (Cohort 1) The combination of palbociclib and pembrolizumab (Cohort 2) Pfizer and Merck, pharmaceutical companies, are supporting this research study by providing the study drugs as well as funding for research activities.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or cytologically confirmed disease from any solid tumor (Cohort 1)
- Participants must have histologically or cytologically confirmed disease from breast cancer or melanoma (Cohort 2).
- Participants must have measurable disease in the CNS, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10...
- Participants must have progressive CNS lesions, as defined by one of the following:
- Patients may have multiple progressive CNS lesions, some of which have been treated by SRS or surgery. Patients are eligible if they have one or more...
You likely can't join if
- Prior treatment with CDK4/6 inhibitor.
- Participants who have had chemotherapy, immunotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the...
- Participants who are receiving any other investigational agents.
- Participants who are receiving other concurrent chemotherapies or immunotherapies for their cancer (except for patients who will receive letrozole...
- Leptomeningeal involvement of cancer (Cohort 1). Leptomeningeal involvement is allowed for Cohort 2.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib (including abemaciclib).
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed disease from any solid tumor (Cohort 1)
- Participants must have histologically or cytologically confirmed disease from breast cancer or melanoma (Cohort 2).
- Participants must have measurable disease in the CNS, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm.
- Participants must have progressive CNS lesions, as defined by one of the following:
- Patients may have multiple progressive CNS lesions, some of which have been treated by SRS or surgery. Patients are eligible if they have one or more un-treated (by surgery or SRS) progressive lesions that is measurable.
- Patients have measurable residual or progressive lesions after surgery.
- Patients who have had prior WBRT and/or SRS are eligible but there needs to be unequivocal evidence of progression of at least one lesion treated by radiation (e.g. tissue diagnosis). Biopsy can be considered for...
- Patients who have previously been treated with systemic therapy for CNS metastases are eligible.
- Age \> 18 years. The toxicity of palbociclib in children is unknown.
- ECOG performance status of 0, 1 or 2 (Karnofsky ≥ 60, see Appendix A).
- Participants must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- hemoglobin ≥9g/dL
- total bilirubin \ 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range.
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (Cohort 1)
- creatinine clearance ≥30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (Cohort 2)
- baseline QTc \<480ms
- The effects of palbociclib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control...
- Ability to understand and the willingness to sign a written informed consent document.
- Tissue from a prior biopsy or resection of intracranial or extracranial site (primary or metastatic site) for clinical genetic sequencing (at least one FFPE block or 15 unstained slides). Patients previously assessed...
- Presence of alteration in CDK pathway in any biopsy or resection (amplifications in CDK4, CDK6, CCND1, CCND2, CCND3 or CCNE1 or loss of CDKN2A) as described in Section 9.2 using a CLIA-certified assay (Cohort 1 only).
- Patients with progressive extracranial disease will not be excluded.
- Stable dose of corticosteroids for at least 7 days.
- Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to enrollment
- Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention
- Hepatits B screening tests are not required unless:
- Known history of HBV infection
- As mandated by local health authority
- Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
- Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to enrollment
- Heptatits C screening tests are not required unless:
- Known history of HCV infection
- As mandated by local health authority
What rules you out
- Prior treatment with CDK4/6 inhibitor.
- Participants who have had chemotherapy, immunotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have ≥ grade 2 adverse events due to agents...
- Participants who are receiving any other investigational agents.
- Participants who are receiving other concurrent chemotherapies or immunotherapies for their cancer (except for patients who will receive letrozole, anastrozole, exemestane, tamoxifen, fulvestrant, trastuzumab...
- Leptomeningeal involvement of cancer (Cohort 1). Leptomeningeal involvement is allowed for Cohort 2.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib (including abemaciclib).
- Participants receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A isoenzymes are ineligible. Lists including medications and substances known or with the potential to...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Pregnant women are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment...
- HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with palbociclib. In addition, these participants are at increased risk of lethal...
- Current use of drugs that are known to prolong the QT interval (See Appendix C).
- Unable to undergo MRI scans.
- QTc \> 480 msec (based on the mean value of the triplicate ECGs), family or personal history of long or short QTc prolongation, or Torsade de Pointes (TdP).
- Uncontrolled electrolyte disorders that can compound the effects of QTc-prolonging drug (eg. hypocalcemia, hypokalemia, hypomagnesemia).
- Active auto immune disease (Cohort 2)
- Patients with history of lung radiation (Cohort 2)
- Prior treatment with PD-1 or PD-L1 blocking agent (Cohort 2)
- History of allogenic transplant
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- History of Hepatitis B or known active Hepatitis C virus infection
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.