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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
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

CLOVER Trial 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.

CLOVER Trial 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.

CLOVER Trial 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%
Cough
7%
Dry Skin
7%
Dehydration
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab

CLOVER 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
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,245 Previous Clinical Trials
288,529,241 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03509012 — Phase 1
Small Cell Lung Cancer 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
Small Cell Lung Cancer 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

Frequently Asked Questions

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

Are there any available openings in this medical study for new participants?

"According to the latest data posted on clinicaltrials.gov, this medical trial is not presently searching for participants - it was originally published in May 2018 and last edited in September 2022. Fortunately, there are 6,005 other studies actively seeking individuals at present."

Answered by AI

How many participants are enrolled in the current clinical trial?

"Recruitment for this trial has been terminated, as the last edit to its listing was made on September 27th 2022. However, there are currently 4061 clinical trials recruiting patients with small cell lung cancer and 1944 studies looking for participants that can be enrolled in a Tremelimumab-related investigation."

Answered by AI

Could I qualify for participation in this research?

"This clinical trial is aiming to enroll 105 individuals, aged between 18 and 110 years old and diagnosed with small cell lung carcinoma. Furthermore, they must have not had any prior exposure to immunotherapy or therapeutic anticancer vaccines, possess a World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0 or 1 as well as having at least one detectable lesion that has yet to be irradiated."

Answered by AI

Does this medical experiment permit individuals over sixty years old to participate?

"This medical study is open to patients aged 18 and over, up until the age of 110."

Answered by AI

Could you provide me with a summary of the research surrounding Tremelimumab?

"The initial trials of Tremelimumab date back to 1997 at the City of Hope Comprehensive Cancer Center. Since then, 2778 clinical studies have been completed with 1944 still active; a vast majority are based in Tucson, Arizona."

Answered by AI

What is the chief therapeutic purpose for which Tremelimumab is regularly prescribed?

"Tremelimumab is a reliable treatment option for metastatic ureter urothelial carcinoma, as well as lymphoma, non-hodgkin's disease, merkel cell cancer and locally advanced cases of non-small cell lung cancer."

Answered by AI

Has Tremelimumab obtained the seal of approval from the United States Food and Drug Administration?

"With limited evidence in support of its efficacy and safety, Tremelimumab has been tentatively assigned a score of 1."

Answered by AI
~15 spots leftby Apr 2025