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Alkylating agents

Immunotherapy + Chemoradiation for Cancer (CLOVER Trial)

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

No prior exposure to immune-mediated therapy (including therapeutic anticancer vaccines)

Body weight >30 kg at enrollment and treatment assignment

Must not have

Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies)

Has a paraneoplastic syndrome (PNS) of autoimmune nature

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose until disease progression, or death, in the absence of progression, assessed up to 4 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat advanced solid tumors. It will evaluate how well the drugs work and how safe they are.

Who is the study for?

This trial is for adults with advanced solid tumors, including various types of lung and oral cancers. Participants must have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory, weigh over 30 kg, have at least one measurable lesion not previously treated with radiation, and no prior immune therapy. Exclusions include multiple primary malignancies, brain metastases, autoimmune disorders, certain specific cancer exclusions per cohort (e.g., unresectable head and neck cancers), paraneoplastic syndromes of autoimmune nature, mixed histology lung cancers, active infections like TB or HIV.

What is being tested?

The study tests the safety and effectiveness of durvalumab alone or combined with tremelimumab alongside chemoradiation therapies such as Etoposide, Pemetrexed, Carboplatin/Cisplatin at varying doses levels paired with external beam radiation (standard/hyperfractionated). It's an early-phase trial to see how well patients tolerate this combination treatment for their advanced solid tumors.

What are the potential side effects?

Potential side effects may include typical chemotherapy-related issues like nausea and fatigue; immunotherapy-related risks such as inflammation in different body parts; infusion reactions from the drugs being administered intravenously; increased risk of infection due to lowered immunity; skin reactions from radiation therapy.

Eligibility Criteria

Inclusion Criteria

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

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I have never received immune therapy or cancer vaccines.

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I weigh more than 30 kg.

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I am fully active or can carry out light work.

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I have at least one tumor that can be measured and has not been treated with radiation.

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I know my HPV status for my throat cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active infections like TB, hepatitis B/C, or HIV.

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I have an autoimmune-related syndrome caused by my cancer.

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My head and neck cancer is not in the mouth, voice box, throat, or below the throat and its origin is known.

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I have more than one primary cancer or tumors in both sides of a body part.

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I have or had an autoimmune or inflammatory disorder.

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My lung cancer is a mix of small cell and non-small cell types.

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I have cancer that has spread to my brain or spinal cord.

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My small cell lung cancer is in the extensive stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose until disease progression, or death, in the absence of progression, assessed up to 4 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose until disease progression, or death, in the absence of progression, assessed up to 4 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose until disease progression, or death, in the absence of progression, assessed up to 4 years. for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Best objective response (BoR)

Duration of response (DoR)

Objective response rate (ORR)

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407

38%

Fatigue

21%

Diarrhea

17%

Nausea

17%

Fever

17%

Anorexia

17%

Maculopapular rash

17%

Pruritus

14%

Constipation

14%

Rash maculo-papular

10%

Anemia

10%

Abdominal pain

10%

Itching

Hypothyroidism

Non-cardiac chest pain

Weight loss

Cough

Dry Skin

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab and Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: SCLC Arm 4Experimental Treatment6 Interventions

Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin Note: Arm 4 will only be opened if the regimen in SCLC Arm 2 is safe and tolerable.

Group II: SCLC Arm 3Experimental Treatment6 Interventions

Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin. Note: Arm 3 will only be opened if the regimen in SCLC Arm 1 is safe and tolerable.

Group III: SCLC Arm 2Experimental Treatment5 Interventions

Patients with limited-stage small-cell lung cancer (SCLC) should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin

Group IV: SCLC Arm 1Experimental Treatment5 Interventions

Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin

Group V: NSCLC Arm 3Experimental Treatment5 Interventions

Investigator's choice of carboplatin and pemetrexed OR cisplatin and pemetrexed

Group VI: NSCLC Arm 2Experimental Treatment4 Interventions

Durvalumab + carboplatin and paclitaxel with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC)

Group VII: NSCLC Arm 1Experimental Treatment4 Interventions

Durvalumab + cisplatin and etoposide with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC)

Group VIII: HNSCC Arm 1Experimental Treatment3 Interventions

Durvalumab + cisplatin with radiation in patients with locally advanced squamous cell carcinoma of the head and neck (HNSCC)

Treatment

First Studied