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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
Must not have
Patients receiving chronic, high dose systemic treatment with corticosteroids defined as: chronic use of cortisone >50mg; hydrocortisone >40mg, prednisone >10mg, methylprednisone >8mg or dexamethasone >1.5mg; or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed
Any severe and/or uncontrolled medical conditions or other conditions that could affect subject participation in the study including: Chronic autoimmune disease
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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have finished all initial cancer treatments and any side effects are mild, except for hair loss or nerve issues.
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My bone marrow test shows cancer cells after all treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on high doses of steroids or other immune-weakening medicines.
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I do not have any severe autoimmune diseases.
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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.
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I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and toxicity is assessed from the first dose of study treatment through 30 days after the last dose of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the efficacy of HCQ or Avelumab, alone or in combination with Palbociclib, in eradicating DTCs
Secondary study objectives
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 • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Endocrine disorders
6%
General disorders and administration site conditions
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
Investigations
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
Infections and infestations
6%
Immune system 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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Hydroxychloroquine
FDA approved
Avelumab
FDA approved
Palbociclib
FDA approved

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,407 Total Patients Enrolled
40 Trials studying Breast Cancer
35,217 Patients Enrolled for Breast Cancer
Abramson Cancer Center at Penn MedicineLead Sponsor
413 Previous Clinical Trials
164,534 Total Patients Enrolled
45 Trials studying Breast Cancer
60,791 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityOTHER
2,323 Previous Clinical Trials
14,874,211 Total Patients Enrolled
28 Trials studying Breast Cancer
23,455 Patients Enrolled for Breast Cancer

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04841148 — Phase 2
Breast Cancer Research Study Groups: Avelumab, Palbociclib and HCQ, HCQ, Palbociclib and Avelumab
Breast Cancer Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT04841148 — Phase 2
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04841148 — Phase 2
~22 spots leftby Nov 2025
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