What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC) include surgery, radiation therapy, and systemic therapies such as chemotherapy and immunotherapy. Specifically, PD-1/PD-L1 inhibitors, which are used to enhance the immune response against cancer cells, can cause a range of side effects. These include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions like rash and pruritus. Less commonly, they may cause vitiligo, alopecia, and severe autoimmune conditions like bullous pemphigoid. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Pembrolizumab and nivolumab are FDA-approved PD-1 inhibitors used in the treatment of squamous cell carcinoma, including head and neck squamous cell carcinoma (HNSCC). These drugs enhance the immune response against cancer cells by blocking the PD-1/PD-L1 interaction. Pembrolizumab has shown efficacy in improving overall survival when used alone or in combination with chemotherapy, as demonstrated in the KEYNOTE-048 trial. Nivolumab is also approved for use in patients with recurrent or metastatic HNSCC who have progressed on or after platinum-based chemotherapy.

What other types of research exist?

Promising novel alternatives to PD-1/PD-L1 inhibitors for Squamous Cell Carcinoma patients include: 1) Farnesyltransferase inhibitors like tipifarnib, which have shown objective response rates of up to 56% in phase II trials for HRAS mutant SCC. 2) Pembrolizumab plus cetuximab, which demonstrated a 45% overall response rate in a phase II trial for treatment-refractory metastatic SCC. 3) Metronomic chemotherapy, which uses frequent, lower doses of chemotherapy to target tumor angiogenesis and minimize toxicity, though it remains investigational.

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PD-L1 Inhibitor

Combination Therapy for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to specified timepoints (1, 2, 3, and 5 years

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial tests several treatments to find the best one for patients with advanced head and neck cancer who haven't been treated before and have specific markers. The treatments likely help the immune system fight cancer. Previous research established the use of pembrolizumab, with or without chemotherapy, as an initial treatment for eligible patients with advanced head and neck cancer.

Who is the study for?

This trial is for adults with Stage III-IVA squamous cell carcinoma of the head and neck (SCCHN) that's resectable, HPV-negative, and PD-L1-positive. They should not have had previous systemic treatments for SCCHN, must be in good health with proper organ function, no severe infections recently, and cannot be pregnant or breastfeeding.

What is being tested?

The study tests combinations of Atezolizumab (an immunotherapy drug), Tiragolumab (another immunotherapy), Carboplatin and Paclitaxel (chemotherapy drugs) on patients who haven't been treated before. It's a randomized trial to see which combination works best at treating this type of cancer.

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in organs, infusion reactions from the drugs entering the body, blood disorders due to chemotherapy agents affecting bone marrow production, fatigue from treatment burden on the body’s resources, as well as increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from surgery to specified timepoints (1, 2, 3, and 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from surgery to specified timepoints (1, 2, 3, and 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgery to specified timepoints (1, 2, 3, and 5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic Complete Response (pCR), as Determined by Local Pathologic Review

Secondary study objectives

Duration of Delayed Surgery Due to Treatment-Related Adverse Events

Event-Free Survival (EFS)

Landmark EFS

+10 more

Awards & Highlights

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Atezo + Tira + CPExperimental Treatment4 Interventions

Participants in the atezolizumab plus tiragolumab plus carboplatin plus paclitaxel arm arm will receive treatment for two cycles (6 weeks) until surgery or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.

Group II: Atezo + TiraActive Control2 Interventions

Participants in the atezolizumab plus tiragolumab arm will receive treatment for two cycles (6 weeks) until surgery or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tiragolumab

Not yet FDA approved

Atezolizumab

FDA approved

Paclitaxel

FDA approved

Carboplatin

FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The PD-1/PD-L1 pathway plays a crucial role in downregulating the immune system and promoting self-tolerance by suppressing T-cell inflammatory activity. Cancer cells often exploit this pathway to avoid being attacked by the body's immune system. PD-1/PD-L1 inhibitors, such as pembrolizumab and nivolumab, block the interaction between PD-1 receptors on T-cells and PD-L1 on cancer cells, thereby enhancing the immune response against the tumor. This mechanism is particularly important for Squamous Cell Carcinoma patients as it can lead to improved recognition and destruction of cancer cells by the immune system, potentially leading to better clinical outcomes.

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