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Monoclonal Antibodies
Avelumab + Palbociclib/Hydroxychloroquine for Breast Cancer (PALAVY Trial)
Phase 2
Recruiting
Led By Angela DeMichele, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have completed all primary and adjuvant therapy (including surgery, chemotherapy, and radiation) with the exception of adjuvant endocrine therapy. Prior treatment-related toxicity must be resolved to ≤ Grade 1 with the exception of alopecia and peripheral neuropathy, prior to study enrollment
Bone marrow aspirate after completion of all definitive therapy demonstrates detectable DTCs (via IHC) as performed by central laboratory assessment at University of Pennsylvania
Timeline
Screening 3 weeks
Treatment Varies
Follow Up toxicity is assessed from the first dose of study treatment through 30 days after the last dose of study treatment
Awards & highlights
PALAVY Trial Summary
This trial will test if a combination of drugs is safe and effective in treating early-stage breast cancer patients with DTCs in the bone marrow.
Who is the study for?
This trial is for adults over 18 with early-stage ER+ breast cancer, who've completed primary and adjuvant therapy (except endocrine therapy), have no recurrent disease, and DTCs detected in bone marrow. They must not have had another invasive breast cancer or severe medical conditions like uncontrolled heart disease, lung dysfunction, or liver disease.Check my eligibility
What is being tested?
The trial tests the safety and efficacy of Hydroxychloroquine (HCQ) or Avelumab with/without Palbociclib on patients with dormant breast cancer cells post-surgery. It aims to see if these treatments can eliminate disseminated tumor cells in the bone marrow.See study design
What are the potential side effects?
Possible side effects include immune-related reactions from Avelumab, eye problems from HCQ, and blood count changes due to Palbociclib. Patients may also experience fatigue, nausea, diarrhea, risk of infection and potential drug interactions.
PALAVY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have finished all initial cancer treatments and any side effects are mild, except for hair loss or nerve issues.
Select...
My bone marrow test shows cancer cells after all treatments.
PALAVY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ toxicity is assessed from the first dose of study treatment through 30 days after the last dose of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~toxicity is assessed from the first dose of study treatment through 30 days after the last dose of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the efficacy of HCQ or Avelumab, alone or in combination with Palbociclib, in eradicating DTCs
Secondary outcome measures
Determine the safety and tolerability of HCQ or Avelumab, alone or in combination with Palbociclib, in this Phase II study: adverse events
Estimate the risk of recurrence after treatment with Palbociclib, Avelumab and HCQ, alone or in combination
Side effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Endocrine disorders
6%
Cardiac disorders
6%
General disorders and administration site conditions
6%
Nervous system disorders
6%
Infections and infestations
6%
Investigations
6%
Gastrointestinal disorders
6%
Metabolism and nutrition disorders
6%
Blood and lymphatic system disorders
6%
Respiratory, thoracic and mediastinal disorders
6%
Neoplasms benign, malignant and unspecified
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
PALAVY Trial Design
4Treatment groups
Experimental Treatment
Group I: Palbociclib and HCQExperimental Treatment2 Interventions
Patients will receive Palbociclib 75 mg daily, by mouth on D1-28 concurrently with HCQ, 600 mg twice daily D1-28 of each 28-day cycle.
Group II: Palbociclib and AvelumabExperimental Treatment2 Interventions
Patients will receive Palbociclib 125 mg daily, by mouth on D1-21 concurrently with Avelumab, 10 mg/kg IV on D1 and D15 of each 28-day cycle
Group III: HCQExperimental Treatment1 Intervention
Patients will receive HCQ, 600 mg twice daily D1-28 of each 28-day cycle.
Group IV: AvelumabExperimental Treatment1 Intervention
Patients will receive Avelumab, 10 mg/kg, IV, D1 and D15 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved
Palbociclib
FDA approved
Hydroxychloroquine
FDA approved
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
104,968 Total Patients Enrolled
41 Trials studying Breast Cancer
35,237 Patients Enrolled for Breast Cancer
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,568 Total Patients Enrolled
44 Trials studying Breast Cancer
60,753 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityOTHER
2,260 Previous Clinical Trials
14,820,684 Total Patients Enrolled
27 Trials studying Breast Cancer
23,412 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your EKG shows that your QT interval is longer than 480 milliseconds.I am on high doses of steroids or other immune-weakening medicines.I don't have any health conditions that would prevent me from taking the study drugs.I do not have any severe autoimmune diseases.I have finished all initial cancer treatments and any side effects are mild, except for hair loss or nerve issues.I am 18 years old or older.I had stage II-III breast cancer that was ER+ and Her2-, treated with the goal of cure, and currently show no signs of the cancer returning.I stopped any CDK4/6 inhibitor treatment, except Palbociclib, over 6 months ago.I have not had invasive breast cancer before, but if I had non-invasive breast cancer or another cancer, it was over 5 years ago.I am currently on hormone therapy for cancer and started it 2-7 years ago.My breast cancer is ER positive and HER2 negative.My blood, liver, and kidney tests are within normal ranges.Criterion: You have a history of certain heart, lung, diabetes, liver, HIV, gastrointestinal, and eye conditions, or active severe infections, which make you ineligible for the study.I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.I am currently on bone-strengthening medication and can continue it during the study.My bone marrow test shows cancer cells after all treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Avelumab
- Group 2: Palbociclib and HCQ
- Group 3: HCQ
- Group 4: Palbociclib and Avelumab
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many venues are participants in this trial being examined?
"The Indiana University in Indianapolis, the University of Chicago in Chicago, and Vanderbilt University in Nashville are among the clinical trial sites currently enrolled. Additionally, there are 5 other centres taking part."
Answered by AI
Are there any research initiatives involving Avelumab that have been undertaken?
"In 2007, Avelumab's testing was initiated at University of Nebraska Medical Centre. Since then 257 trials have been finished and presently 301 are actively recruiting in locations such as Indianapolis, Indiana."
Answered by AI
What ailments is Avelumab regularly prescribed to address?
"Avelumab is regularly employed to treat q fever, though it has also been used with success for treating advanced directives, malaria, and sjögren's syndrome."
Answered by AI
Is there an opportunity to participate in this clinical experimentation?
"Clinicaltrials.gov reveals that this trial is currently seeking participants, with enrollment starting on June 1st 2021 and the description last updated on September 9th 2022."
Answered by AI
What is the current standing of Avelumab with regards to federal regulatory approvals?
"Our ratings suggest that avelumab is relatively safe, being assigned a score of 2. This reflects the fact that while safety has been documented in phase two trials, efficacy data remains unavailable."
Answered by AI
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