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Chemotherapy

Magrolimab Combo for Cancer (ELEVATE HNSCC Trial)

Q: How is Magrolimab most often utilized?

<p>Magrolimab is most often used to treat <a href="https://www.withpower.com/clinical-trials/actinic-keratosis">actinic keratosis</a>. However, it has also been found effective in treating hodgkin disease, metastatic cutaneous <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>, and other medical conditions.</p>

Phase 2

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HNSCC per protocol specified inclusion criteria regardless of PD-L1 status

Should not have had prior systemic therapy administered in the recurrent or metastatic setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

ELEVATE HNSCC Trial Summary

This trial is studying magrolimab in combination with pembrolizumab + 5-fluorouracil (5-FU) + platinum chemotherapy, and docetaxel in combination with magrolimab in participants with head and neck squamous cell carcinoma (HNSCC).

Who is the study for?

This trial is for individuals with head and neck squamous cell carcinoma who haven't had systemic therapy in the recurrent/metastatic setting. Eligible tumor locations include oropharynx, oral cavity, hypopharynx, and larynx but not nasopharynx. Participants should have no more than two prior systemic therapies for advanced cancer and can't join if they've had certain immune treatments or a history of pneumonitis.Check my eligibility

What is being tested?

The study tests magrolimab's safety and effectiveness when combined with other cancer drugs (Docetaxel, 5-FU, Cisplatin, Carboplatin) in patients with head and neck cancers. It aims to determine proper dosing and tolerability of this combination therapy.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to medication components, fatigue from treatment regimens, digestive issues like nausea or diarrhea from chemotherapy drugs, blood disorders such as anemia or clotting problems due to bone marrow suppression.

ELEVATE HNSCC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have head and neck cancer, PD-L1 status doesn't matter.

Select...

I haven't had systemic therapy for cancer that came back or spread.

Select...

My head or neck cancer has spread or returned and cannot be cured with surgery or radiation.

Select...

My cancer is advanced but has been treated with 1 or 2 systemic therapies.

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My cancer is in my throat, mouth, or voice box, but not in the upper part of my throat behind the nose.

ELEVATE HNSCC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 2 Cohorts 1: Progression-free Survival (PFS)

Phase 2 Cohorts 2 and 3: Objective Response Rate (ORR)

Safety Run-in Cohorts: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

Secondary outcome measures

Phase 2 Cohorts: Change From Baseline in the 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)

Phase 2 Cohorts: Change from Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35)

Phase 2 Cohorts: Change from Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score

+6 more

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782

67%

Dry skin

44%

Diarrhoea

44%

Dermatitis acneiform

44%

Fatigue

44%

Lymphocyte count decreased

33%

Infusion related reaction

33%

Abdominal pain

22%

Myalgia

22%

Decreased appetite

22%

Small intestinal obstruction

22%

Tinnitus

22%

Nausea

22%

Chills

22%

Oedema peripheral

22%

Back pain

22%

Headache

22%

Pruritus

22%

Dehydration

22%

Rash maculo-papular

11%

Hypokalaemia

11%

Dyspepsia

11%

Tumour pain

11%

Hypertension

11%

Dyspnoea

11%

Lymphopenia

11%

Malignant neoplasm progression

11%

Cerebrovascular accident

11%

Anaemia

11%

Palpitations

11%

Conjunctivitis allergic

11%

Dry eye

11%

Abdominal distension

11%

Constipation

11%

Gastrooesophageal reflux disease

11%

Hypoaesthesia oral

11%

Folliculitis

11%

Sinusitis

11%

Gastrointestinal stoma complication

11%

Aspartate aminotransferase increased

11%

Blood bilirubin increased

11%

Hypomagnesaemia

11%

Hypophosphataemia

11%

Dizziness

11%

Confusional state

11%

Depression

11%

Haematuria

11%

Dysphonia

11%

Ingrowing nail

11%

Skin infection

11%

Tinea cruris

11%

Platelet count decreased

11%

Alanine aminotransferase increased

11%

Photopsia

11%

Conjunctivitis

11%

Gastroenteritis viral

11%

Hyperglycaemia

11%

Arthralgia

11%

Neck pain

11%

Somnolence

11%

Nasal congestion

11%

Deep vein thrombosis

11%

Oesophageal pain

11%

Vomiting

11%

Chest discomfort

100%

80%

60%

40%

20%

Study treatment Arm

Magrolimab 10 mg/kg

Magrolimab 20 mg/kg

Magrolimab 30 mg/kg

Magrolimab 45 mg/kg

Magrolimab Priming Dose Only

ELEVATE HNSCC Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Safety Run-in Cohort 2, Magrolimab + DocetaxelExperimental Treatment2 Interventions

Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive the following: magrolimab docetaxel 75 mg/m^2 on Day 1 of each cycle Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days.

Group II: Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + PlatinumExperimental Treatment5 Interventions

Participants with untreated metastatic or unresectable, locally recurrent head and neck squamous cell carcinoma (HNSCC) regardless of programmed cell death ligand 1 (PD-L1) status will receive the following: magrolimab pembrolizumab 200 mg on Day 1 of each cycle 5-fluorouracil (5-FU) 1000 mg/m^2/day Days 1-4 of each cycle (for up to 6 cycles) platinum chemotherapy (cisplatin 100 mg/m^2 or carboplatin area under the concentration versus time curve (AUC) 5 per investigator choice (for up to 6 cycles)) Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the recommended Phase 2 dose (RP2D) is determined. Each cycle is 21 days.

Group III: Pre-expansion Safety Run-in Cohort, Magrolimab + PembrolizumabExperimental Treatment2 Interventions

The pre-expansion safety run-in cohort may be conducted at the sponsor's discretion prior to the initiation of Phase 2 Cohort 2. Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) ≥ 1 will receive magrolimab and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days. Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days.

Group IV: Phase 2 Cohort 3, Magrolimab + DocetaxelExperimental Treatment2 Interventions

Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive magrolimab at the RP2D determined in the Safety run-in cohort 2 and docetaxel 75 mg/m^2 on Day 1 of each cycle. Each cycle is 21 days. Magrolimab and docetaxel will be continued until loss of clinical benefit, unacceptable toxicity, or death.

Group V: Phase 2 Cohort 2, Magrolimab + PembrolizumabExperimental Treatment2 Interventions

Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) ≥ 1 will receive magrolimab at the RP2D determined in the Safety run-in cohort 1 and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.

Group VI: Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C)Experimental Treatment5 Interventions

Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, zimberelimab 360 mg on Day 1 of each cycle, 5-FU 1000 mg/m^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Zimberelimab therapy will be administered up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.

Group VII: Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A)Experimental Treatment5 Interventions

Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.

Group VIII: Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B)Active Control4 Interventions

Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~5620

5-FU

2014

Completed Phase 3

~3420

Cisplatin

2013

Completed Phase 3

~1940

Carboplatin

2014

Completed Phase 3

~6670

Zimberelimab

2018

Completed Phase 1

~50

Magrolimab

2021

Completed Phase 2

~170

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,082 Previous Clinical Trials

842,523 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,517 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for new participants in this experiment?

"From what is indicated on clinicaltrials.gov, it appears that this study is still recruiting patients. The first posting was on September 7th, 2021 and the most recent update was on November 4th, 2022."

Answered by AI

How many patients are included in this clinical trial currently?

"The planned clinical study will require 230 patients that meet the necessary requirements. Gilead Sciences, the sponsor of the trial, will be using different locations to test subjects including New york Cancer and Blood Specialists in Port Jefferson Station, New York and MD Anderson Cancer Center in Houston, Texas."

Answered by AI

How is Magrolimab most often utilized?

"Magrolimab is most often used to treat actinic keratosis. However, it has also been found effective in treating hodgkin disease, metastatic cutaneous squamous cell carcinoma, and other medical conditions."

Answered by AI

In how many different medical institutions is this research project being conducted presently?

"There are a total of 18 sites where this clinical trial is being offered, these locations include: New york Cancer and Blood Specialists in Port Jefferson Station, MD Anderson Cancer Center in Houston, Sanford Roger Maris Cancer Center in Fargo; as well as 15 other centres."

Answered by AI

What is the status of Magrolimab's FDA approval?

"Magrolimab safety is graded as a 2. This evaluation comes from the fact that this medication is still in Phase 2 clinical trials. Although there are reports suggesting it is safe, none have yet evaluated its efficacy."

Answered by AI

What other research studies have included Magrolimab?

"The first clinical trial for magrolimab was completed in 1997 at City of Hope Comprehensive Cancer Center. As of right now, there have been a total of 2915 clinical trials with 2443 still ongoing. The majority of these active studies are based out of Port Jefferson Station, New york."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

2021. "Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04854499.

All > Squamous Cell Carcinoma