What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include chemotherapy regimens such as oxaliplatin-based therapies and fluoropyrimidines (e.g., fluorouracil and capecitabine). These treatments are associated with side effects like neuropathy, hand-foot syndrome, diarrhea, nausea, vomiting, stomatitis, fatigue, and partial alopecia. Immunotherapy options, such as PD-1 inhibitors like Dostarlimab, can cause immune-related adverse events including pneumonitis, rash, pruritus, and endocrine disorders. Severe adverse effects are less common but can include severe infections and organ-specific toxicities.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of colorectal cancer, particularly for cases with specific genetic markers such as dMMR (defective mismatch repair) or MSI-H (microsatellite instability-high). Pembrolizumab (Keytruda) and nivolumab (Opdivo) are PD-1 inhibitors approved for metastatic colorectal cancer that has progressed following prior treatment. These approvals are based on the efficacy of these drugs in targeting the PD-1 pathway, which helps the immune system recognize and attack cancer cells. The trial of dostarlimab, another PD-1 inhibitor, is being studied for its potential in treating resectable colon cancer with similar genetic markers.

What other types of research exist?

Promising alternatives to Dostarlimab for colorectal cancer patients include Pembrolizumab and Nivolumab, both of which are PD-1 inhibitors. Additionally, combination therapies involving PD-1 inhibitors with chemotherapy, such as Pembrolizumab plus FOLFOX, are being explored and show potential. Emerging therapies like personalized antibodies and novel immunotherapy combinations are also under investigation and may offer new options in the near future.

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Chemotherapy

Dostarlimab for Colon Cancer (AZUR-2 Trial)

Phase 3

Recruiting

Research Sponsored by GlaxoSmithKline

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 up to approximately 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing dostarlimab, a drug that helps the immune system fight cancer. It targets patients with a specific type of colon cancer that has certain genetic features and can be surgically removed. Dostarlimab works by helping the immune system recognize and destroy cancer cells.

Who is the study for?

This trial is for individuals with untreated T4N0 or Stage III colon cancer that can be surgically removed and shows either dMMR status or MSI-H. Participants should not have had any prior treatments for colon cancer, no distant metastatic disease, and must not require urgent surgery due to bowel obstruction.

What is being tested?

The study tests the effectiveness of dostarlimab given around the time of surgery compared to standard chemotherapy regimens (CAPEOX or FOLFOX) in patients with specific types of resectable colon cancer. The goal is to see if dostarlimab improves outcomes.

What are the potential side effects?

Dostarlimab may cause allergic reactions, immune-related issues like inflammation in organs, fatigue, digestive problems, skin reactions, and could potentially worsen pre-existing conditions such as lung disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 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

Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)

Secondary study objectives

Event-free Survival (EFS) assessed by local assessment

Number of Participants with Pathological Response

Overall Survival (OS)

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT04409002

80%

Anemia

80%

Fatigue

73%

Abdominal pain

67%

CD4 lymphocytes decreased

67%

Alkaline phosphatase increased

67%

Nausea

60%

Anorexia

60%

Constipation

53%

Platelet count decreased

53%

Hyperglycemia

47%

Thromboembolic event

47%

Weight loss

47%

Anxiety

47%

Hypoalbuminemia

40%

Vomiting

40%

Peripheral motor neuropathy

40%

Blood bilirubin increased

40%

Dyspnea

40%

Hypertension

33%

Edema limbs

33%

Abdominal distension

33%

Aortic valve disease

33%

Back pain

33%

Diarrhea

33%

Fever

33%

Hypocalcemia

33%

Sinus tachycardia

27%

Depression

27%

White blood cell decreased

27%

Chills

27%

Ascites

27%

Hyponatremia

20%

Pain

20%

Sore throat

20%

Paresthesia

20%

Urine discoloration

20%

Delirium

20%

Cough

20%

Dizziness

20%

Lymphocyte count decreased

13%

Palpitations

13%

Insomnia

13%

Neutrophil count decreased

13%

Thrush

13%

Pain in extremity

13%

Confusion

13%

Dehydration

13%

Fall

13%

Cardiac troponin T increased

13%

Alanine aminotransferase increased

13%

Aspartate aminotransferase increased

13%

Bloating

13%

Dry mouth

13%

Dysphagia

13%

Dysuria

13%

Flatulence

13%

Gastroesophageal reflux disease

13%

Glucosuria

13%

Hiccups

13%

Hypercalcemia

13%

Hyperkalemia

13%

Hypokalemia

13%

Hypophosphatemia

13%

Hypothyroidism

13%

Localized edema

Oral pain

Hematuria

Stroke

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Obesity

Skin infection

Superficial thrombophlebitis

Urinary retention

Tremor

Papulopustular rash

Thyroid stimulating hormone increased

Hemorrhoidal hemorrhage

Erectile dysfunction

Skin ulceration

Osteoporosis

Urinary frequency

Oral hemorrhage

Generalized muscle weakness

Encephalopathy

Endocarditis infective

Eye disorders - Other, specify

Pelvic pain

Prostatic obstruction

Pruritus

Rash acneiform

Rectal pain

Renal calculi

Reproductive system and breast disorders - Other, specify

Wheezing

Portal vein thrombosis

Vaginal dryness

Alopecia

Arthralgia

Arthritis

Bacteremia

Biliary tract infection

Blood lactate dehydrogenase increased

Buttock pain

Dry skin

Dysgeusia

Flank pain

Gastric anastomotic leak

Gastric ulcer

Gastritis

Gastrointestinal disorders - Other, specify

Gastrointestinal pain

Hyperlipidemia

Hypoglycemia

Lethargy

Memory impairment

Mucositis oral

Muscle cramp

Muscle weakness lower limb

Myocarditis

Restlessness

Scleral disorder

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Niraparib+Dostarlimab + Radiation

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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: DostarlimabExperimental Treatment1 Intervention

Participants will receive Dostarlimab pre and post surgery

Group II: Standard of Care (SOC)Active Control2 Interventions

Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dostarlimab

2020

Completed Phase 3

~1760

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 most common treatments for colorectal cancer include chemotherapy, targeted therapies, and immune checkpoint inhibitors. Chemotherapy drugs, such as fluorouracil, oxaliplatin, and irinotecan, work by interfering with the DNA replication process, thereby killing rapidly dividing cancer cells. Targeted therapies, like cetuximab and bevacizumab, focus on specific molecules involved in cancer growth and spread, such as the epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF). Immune checkpoint inhibitors, such as dostarlimab (a PD-1 inhibitor), enhance the body's immune response against cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. These treatments are crucial for colorectal cancer patients as they offer multiple mechanisms to attack the cancer, potentially improving outcomes and providing options when the cancer becomes resistant to one form of therapy.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Monoclonal antibody therapy for solid tumors.