Magrolimab for Carcinoma, Squamous Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
St. Vincent's Hospital Sydney, Darlinghurst, Australia
Carcinoma, Squamous Cell+3 More
Magrolimab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug called magrolimab can improve the survival of people with head and neck cancer.

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Eligible Conditions

  • Carcinoma, Squamous Cell
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Squamous Cell

Study Objectives

This trial is evaluating whether Magrolimab will improve 3 primary outcomes and 9 secondary outcomes in patients with Carcinoma, Squamous Cell. Measurement will happen over the course of First Dose up to 21 days.

Month 24
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
Day 21
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
Up to 5 years
Phase 2 Cohorts 1: Progression-free survival (PFS)
Phase 2 Cohorts: Duration of Response (DOR)
Phase 2 Cohorts: Overall Survival (OS)
Phase 2 Cohorts: Progression-free survival (PFS)
Up to 9 months
Phase 2 Cohorts 2 and 3: Objective Response Rate (ORR)
Phase 2 Cohorts: Objective Response Rate (ORR)
Month 24
Safety Run-In and Phase 2 Cohorts: Percentage of Participants who Developed Antidrug Antibodies (ADAs) to Magrolimab
Safety Run-In and Phase 2 Cohorts: Serum Concentration of Magrolimab

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Carcinoma, Squamous Cell

Trial Design

10 Treatment Groups

Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B)
1 of 10
Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum
1 of 10
Safety Run-in Cohort 2, Magrolimab + Docetaxel
1 of 10
Phase 2 Cohort 3, Magrolimab + Docetaxel
1 of 10
Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A)
1 of 10
Phase 2 Cohort 2, Magrolimab + Pembrolizumab
1 of 10
Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum
1 of 10
Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C)
1 of 10
Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum
1 of 10
Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab
1 of 10
Active Control
Experimental Treatment

This trial requires 230 total participants across 10 different treatment groups

This trial involves 10 different treatments. Magrolimab is the primary treatment being studied. Participants will be divided into 9 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + PlatinumParticipants 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.
Safety Run-in Cohort 2, Magrolimab + DocetaxelParticipants 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.
Phase 2 Cohort 3, Magrolimab + DocetaxelParticipants 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.
Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A)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.
Phase 2 Cohort 2, Magrolimab + PembrolizumabParticipants 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.
Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + PlatinumParticipants 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.
Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C)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 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.
Phase 2 Cohort 1, Pembrolizumab + 5-FU + PlatinumParticipants 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.
Pre-expansion Safety Run-in Cohort, Magrolimab + PembrolizumabThe 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.
Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B)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
Fluorouracil
FDA approved
Zimberelimab
2018
Completed Phase 1
~50
Cisplatin
FDA approved
Docetaxel
FDA approved
Carboplatin
FDA approved
Magrolimab
Not yet FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Stanford Cancer Institute - Palo Alto, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Squamous Cell or one of the other 3 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have histologically or cytologically confirmed metastatic or locally recurrent HNSCC that is considered incurable by local therapies. show original
You have not had prior systemic therapy administered in the recurrent or metastatic setting. show original
You have a primary tumor of the oropharynx, oral cavity, hypopharynx, or larynx. show original
Safety Run-in Cohort 1 and Phase 2 Cohorts 1
HNSCC per protocol specified inclusion criteria regardless of PD-L1 status
Safety Run-in Cohort 2 and Phase 2 Cohort 3
You have locally advanced/metastatic HNSCC and you have received no more than 2 lines of prior systemic anticancer therapy. show original
Key

Patient Q&A Section

Can oral squamous cell carcinoma be cured?

"This case illustrates, in our opinion, the possibility of cure in this type of tumour with only minimal treatment. However, in addition to the local tumour control, adjuvant treatment is important. If the possibility of cure is to be maintained with minimal treatment, close follow-up of the patient and the surgeon is required. We believe this case should serve to provide surgeons with an awareness of the current advances in oral oncology, which have had an influence on the prognosis of OSCC." - Anonymous Online Contributor

Unverified Answer

How many people get oral squamous cell carcinoma a year in the United States?

"3.0 million people in the United States experience an incident oral cancer diagnosis each year. These people experience an 8.6% mortality from the disease and a 30.9% 5 year survival rate. The lifetime risk of oral cancer in the United States is 4%. Oral cancer disproportionately affects African-American and Latino populations. The annual number of new cases in the United States that are not attributed to tobacco or alcohol use is 8.5%." - Anonymous Online Contributor

Unverified Answer

What causes oral squamous cell carcinoma?

"Oral SCC is a multifaceted disease. Over 80% of cancers occur at the site of first contact, which suggests an environmental risk factor for its development. Current smokers and second-hand smoke exposure were associated with increased risk of developing OSCC. Further research is needed to identify more precisely the factors that modify risk for SCC and OSCC." - Anonymous Online Contributor

Unverified Answer

What are common treatments for oral squamous cell carcinoma?

"Osteoperiostitis secondary to radiation therapy with/or chemotherapy presents common treatments for oral cancer. A new treatment, hyperbaric oxygen therapy (HBOT), has been used with some success. HBOT is a novel treatment that can be used concurrently on a more aggressive form of treatment. The mechanism of action is not clear, but HBOT may interfere with growth and spread of cancer cells in the bone microenvironment. Clinical trials have shown it to be safe and a benefit option for a subset of patients. We recommend HBOT as an alternative treatment option for oral squamous cell carcinoma." - Anonymous Online Contributor

Unverified Answer

What are the signs of oral squamous cell carcinoma?

"It is difficult to diagnose early stage ESCC or SCC of the oropharynx in the early stages of carcinoma because the symptoms are not evident until the tumor is in advanced stages. The most important symptom is numbness or paresthesia affecting the head and neck region. In addition, patients with advanced stages or who have undergone radiotherapy are diagnosed late, making it almost impossible to get definitive treatment before the disease progresses to advanced and life-threatening stages." - Anonymous Online Contributor

Unverified Answer

What is oral squamous cell carcinoma?

"The incidence of OSCC in Japan was estimated at 7,090 per 100,000 population. OSCC is one of the 10 most common cancers in Japan. It occurs more frequently in the elderly and is of the lip and nasal cavity type. The most important risk factors are alcohol and smoking. The survival of OSCC patients has improved with progress in medical treatment over the last decades, but they remain unsatisfactorily distributed between socioeconomic classes." - Anonymous Online Contributor

Unverified Answer

Does magrolimab improve quality of life for those with oral squamous cell carcinoma?

"Magrolimab provided significant improvements in QOL for patients with HNSCC. Although there are a number of factors (such as poor prognosis, non-smokers, or pain) that could have affected the study's outcome, these factors are also factors that many patients face with HNSCC. Magrolimab therefore may have a significant impact on QOL for patients with HNSCC." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets oral squamous cell carcinoma?

"Oral SCC incidence increases after age 40, but the percentage of cases in the 40- to 50-year-old age group remains higher than all other reported studies. Overall, the incidence is lowest in individuals younger than 20 years; the average age at diagnosis is lower for men than women. The oral SCC-related deaths are at least 2 years earlier in men compared to women. The age-adjusted overall survival in men is lower than in women. The incidence of oral SCC may be related to socio-economic status and smoking, particularly among women." - Anonymous Online Contributor

Unverified Answer

Has magrolimab proven to be more effective than a placebo?

"Patients receiving magrolimab have significantly fewer lesions and greater lesion size reduction. Although, our results have not demonstrated a statistically significant difference in response rate between placebo and magrolimab, our data suggest further investigation is warranted. Magrolimab has been shown to have an active role in the treatment of cancer with a favorable side effect profile. In a recent study, findings shows magrolimab can be a first line chemotherapeutic agent in cancer treatment." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in magrolimab for therapeutic use?

"Magrolimab seems to be effective in decreasing recurrence after chemoradiotherapy for SCC in the head and neck. Additional studies are needed to evaluate the optimal dosing, route of administration, dose or regimen in order to attain maximal tumor response, tolerability and safety." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving magrolimab?

"Magrolimab may be a promising candidate for the treatment of advanced oral squamous cell carcinomas. Further study should be carried out before any conclusions can be made regarding its use in different clinical settings." - Anonymous Online Contributor

Unverified Answer

How serious can oral squamous cell carcinoma be?

"The severity of SCC was not associated temporally, with the location of SCC, or with smoking prevalence during the lifetime of patients who were eligible for this study. Patients receiving chemotherapy in situ (or post-treatment) had higher grades than those who had not received chemotherapy in situ (and those who had received it prior to referral to this study had a higher grade than those who had not received chemotherapy in situ). The study team did not anticipate, or discuss, the potential for chemotherapy to be associated with higher severity of disease. Results from a recent paper cannot confirm a causal relationship between chemotherapy and disease severity because of the presence of confounding." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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