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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 death due to any cause through study completion, up to 4 years
Awards & highlights

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~from first dose until death due to any cause through study completion, up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose until death due to any cause through study completion, up to 4 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
Number of subjects with Adverse Events (AEs)
Number of subjects with Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Best objective response (BoR)
Disease control rate (DCR)
Disease-free survival (DFS)
+4 more

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407
38%
Fatigue
21%
Diarrhea
17%
Pruritus
17%
Maculopapular rash
17%
Anorexia
17%
Nausea
17%
Fever
14%
Rash maculo-papular
14%
Constipation
10%
Itching
10%
Anemia
10%
Abdominal pain
7%
Dry Skin
7%
Cough
7%
Dehydration
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab

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
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Durvalumab
2017
Completed Phase 2
~3840
Tremelimumab
2017
Completed Phase 2
~3130
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,302 Previous Clinical Trials
288,624,494 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03509012 — Phase 1
Squamous Cell Carcinoma Research Study Groups: SCLC Arm 2, HNSCC Arm 1, NSCLC Arm 1, NSCLC Arm 2, NSCLC Arm 3, SCLC Arm 1, SCLC Arm 3, SCLC Arm 4
Squamous Cell Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03509012 — Phase 1
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03509012 — Phase 1
~15 spots leftby Jul 2025
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