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Monoclonal Antibodies

Dostarlimab for Advanced Cancer (GARNET Trial)

Phase 1

Recruiting

Research Sponsored by Tesaro, Inc.

Eligibility Criteria Checklist

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

Must have

Participants who have progressed on or after platinum doublet therapy

Participants have received no more than 2 lines of anti-cancer therapy for recurrent or advanced (>=Stage IIIB) disease. Prior treatment with hormone therapies is acceptable and does not count towards the number of anti-cancer therapies noted in the criterion above for this cohort.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840 and 1008 hours post dose q6w upto 2 years

Awards & highlights

GARNET Trial Summary

This trial is testing a new drug for people with advanced solid tumors who have limited available treatment options. The study will evaluate the safety and effectiveness of the drug.

Who is the study for?

Adults with advanced solid tumors and limited treatment options can join this trial. They must have specific tumor types, adequate organ function, and an ECOG performance status of <=2 for Part 1 or <=1 for Part 2. Women must not be pregnant and agree to use contraception. Participants cannot have had more than three prior cancer therapies.Check my eligibility

What is being tested?

The study tests dostarlimab (TSR-042), a drug targeting the PD-1 receptor in two parts: dose escalation to find the maximum tolerated dose, then fixed-dose safety evaluation and expansion cohorts focusing on specific tumor types to assess safety and clinical activity.See study design

What are the potential side effects?

Dostarlimab may cause immune-related side effects due to its action on the immune system, which could lead to inflammation in various organs. Other potential side effects include infusion reactions similar to allergic responses, fatigue, digestive issues like nausea or diarrhea, skin reactions, liver enzyme changes.

GARNET Trial Eligibility Criteria

Inclusion Criteria

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

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My condition worsened after platinum-based chemotherapy.

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I've had up to 2 cancer treatments for my advanced disease, not counting hormone therapy.

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My cancer has returned and is advanced.

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I have an EGFR mutation and have been treated with both chemotherapy and an EGFR inhibitor.

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I have 2 scans showing my cancer has grown after my last cancer treatment.

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I have ALK-positive cancer and have been treated with both chemotherapy and an ALK inhibitor.

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I have been treated with platinum, taxane, and bevacizumab for my cancer.

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My cancer returned within 6 months after my last platinum-based treatment.

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My condition worsened after platinum-based chemotherapy.

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My cancer has returned and is advanced.

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My tumor's MMR/MSI status was checked with a certified test.

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I have recurrent ovarian, fallopian tube, or peritoneal cancer with at least one measurable lesion.

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My cancer is endometrial, but not a sarcoma type.

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I have two scans showing my cancer has grown after my last cancer treatment.

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I am 18 years old or older.

GARNET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840 and 1008 hours post dose q6w upto 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840 and 1008 hours post dose q6w upto 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840 and 1008 hours post dose q6w upto 2 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

Pharmaceutical Preparations

Part 1: Number of participants with abnormal clinical chemistry parameters

Part 1: Number of participants with abnormal electrocardiogram (ECG) parameters

+35 more

Secondary outcome measures

Part 1: Area under the concentration-time curve at steady state (AUC,ss) of dostarlimab

Part 1: Area under the concentration-time curve from time 0 to infinity (AUC, 0-infinity) of dostarlimab

Part 1: Area under the concentration-time curve from time 0 to last (AUC,0-last) assessment of dostarlimab

+41 more

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%

Urine discoloration

20%

Paresthesia

20%

Sore throat

20%

Delirium

20%

Cough

20%

Dizziness

20%

Lymphocyte count decreased

13%

Insomnia

13%

Palpitations

13%

Thrush

13%

Pain in extremity

13%

Neutrophil count decreased

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

Skin ulceration

Oral pain

Obesity

Oral hemorrhage

Encephalopathy

Generalized muscle weakness

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

Osteoporosis

Urinary retention

Papulopustular rash

Skin infection

Endocarditis infective

Erectile dysfunction

Hematuria

Stroke

Thyroid stimulating hormone increased

Hemorrhoidal hemorrhage

Urinary frequency

Superficial thrombophlebitis

Tremor

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

GARNET Trial Design

7Treatment groups

Experimental Treatment

Group I: Part 2B:Cohort F non-endometrial dMMR/MSI-H & POLE-Mut cancersExperimental Treatment1 Intervention

Participants with recurrent or advanced dMMR/MSI-H solid tumors except endometrial cancers, and gastrointestinal cancers, who have received prior systemic therapy and, who have no alternative treatment options. These participants will receive dostarlimab 500 mg for Q3W for the first 4 cycles followed by 1000 mg Q6W for all subsequent cycles.

Group II: Part 2B: Cohort G PROC without known BRCAExperimental Treatment1 Intervention

Participants with advanced, relapsed, high-grade serous, endometrioid, or clear cell ovarian, fallopian tube, or primary peritoneal cancer without known breast cancer susceptibility gene (BRCA) mutation who have platinum-resistant disease receiving dostarlimab and who have also been previously treated with bevacizumab. These participants will receive dostarlimab 500 mg for Q3W for the first 4 cycles followed by 1000 mg Q6W for all subsequent cycles.

Group III: Part 2B: Cohort E NSCLCExperimental Treatment1 Intervention

Part 2B: Cohort E NSCLC will include participants with non-small cell lung cancer (NSCLC) who progressed after at least 1 prior platinum-based systemic chemotherapy regimen for recurrent or advanced disease. These participants will receive dostarlimab 500 mg for Q3W for the first 4 cycles followed by 1000 mg Q6W for all subsequent cycles.

Group IV: Part 2B: Cohort A2 MMR-proficient/MSS endometrial cancerExperimental Treatment1 Intervention

Part 2B: Cohort A2 will include participants with MMR-proficient/MSS endometrial cancer who have progressed on or after platinum doublet therapy. These participants will receive dostarlimab 500 mg for Q3W for the first 4 cycles followed by 1000 mg Q6W for all subsequent cycles. Participants have received no more than 2 lines of anti-cancer therapy for recurrent or advanced (Stage >=IIIB) disease.

Group V: Part 2B: Cohort A1 dMMR/MSI-H endometrial cancerExperimental Treatment1 Intervention

Part 2B: Cohort A1 will include participants with mismatch repair deficient microsatellite instability high (dMMR/MSI-H) endometrial cancer who have progressed on or after platinum doublet therapy. These participants will receive dostarlimab 500 mg for Q3W for the first 4 cycles followed by 1000 mg Q6W for all subsequent cycles. Participants have received no more than 2 lines of anti-cancer therapy for recurrent or advanced (Stage >= IIIB) disease.

Group VI: Part 2A: Participants receiving dostarlimabExperimental Treatment1 Intervention

In Part 2A, participants will receive fixed dose of 500 mg administered Q3W or 1000 mg administered Q6W dose on Day 1 of each cycle. Cycle duration for Q3W dosing is 21 days and Q6W dosing is 42 days. Cohorts will enroll participants with advanced solid tumor using a modified 6+6 design and will follow a 6+6 design.

Group VII: Part 1: Participants receiving dostarlimabExperimental Treatment1 Intervention

Part 1 will evaluate dostarlimab at ascending weight-based doses 1 mg/kg, 3 mg/kg and 10 mg/kg. Higher dose levels 15 mg/kg and/or 20 mg/kg may also be explored. Dostarlimab will be administered intravenously (IV) on Day 1 and Day 15 of each cycle; cycle length is 28 days. Cohorts will be enrolled sequentially and will initially follow a 3+3 design.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dostarlimab

2020

Completed Phase 2

~1000

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor

56 Previous Clinical Trials

9,816 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,190 Total Patients Enrolled

1 Trials studying Tumors

12 Patients Enrolled for Tumors

Media Library

Dostarlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02715284 — Phase 1

Tumors Research Study Groups: Part 2B: Cohort A2 MMR-proficient/MSS endometrial cancer, Part 1: Participants receiving dostarlimab, Part 2A: Participants receiving dostarlimab, Part 2B: Cohort A1 dMMR/MSI-H endometrial cancer, Part 2B: Cohort E NSCLC, Part 2B:Cohort F non-endometrial dMMR/MSI-H & POLE-Mut cancers, Part 2B: Cohort G PROC without known BRCA

Tumors Clinical Trial 2023: Dostarlimab Highlights & Side Effects. Trial Name: NCT02715284 — Phase 1

Dostarlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02715284 — Phase 1

Frequently Asked Questions

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

What previous investigations have been undertaken with Dostarlimab?

"Dostarlimab was first examined at City of Hope in 2010, and since then 1 trial has been finalized. As for now, 40 active studies are being conducted, primarily based out of Kansas City."

Answered by AI

Could you share the locations where this experiment is currently being conducted?

"Presently, 50 medical clinics across the United States are enrolling for this clinical trial. It is advisable to choose a clinic in Kansas City, Augusta or Scarborough to minimize travel requirements should you elect to join."

Answered by AI

Are there any vacancies for this research project?

"Affirmative. Data hosted on clinicaltrials.gov is indicative of this study's continued recruitment efforts; the trial was initially posted in March 2016 and most recently modified November 2022, with an aim to assemble 740 patients across 50 sites nationwide."

Answered by AI

Has Dostarlimab been given the green light by the Food and Drug Administration?

"Our team at Power has assigned Dostarlimab a safety rating of 1 since this is an early stage trial, with minimal evidence to validate its efficacy and security."

Answered by AI

How many participants have signed up to take part in this trial?

"Affirmative. Reports hosted on clinicaltrials.gov demonstrate that this medical investigation, first posted on March 7th 2016, is currently recruiting participants. The research requires the recruitment of 740 subjects from 50 different sites."

Answered by AI

What is the ultimate goal of this research project?

"This trial will be ongoing for up to two years and aims to quantify the number of patients experiencing adverse events. Secondary objectives include determining serum levels of dostarlimab, recording progression-free survival times, and calculating disease control rate in Cohort A1 according to RECIST v1.1 criteria."

Answered by AI