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Checkpoint Inhibitor

Nivolumab and Ipilimumab and Combination for Metastatic Cancer for Cancer

Q: How many individuals are meeting the requirements for this research project?

Unfortunately, this particular study is not seeking patients at the moment. However, there are other trials that might be of interest. There are currently 3038 studies actively looking for participants with advanced metastatic <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> and 796 trials for Nivolumab and Ipilimumab and Combination for Metastatic Cancer actively recruiting participants.

Q: What are the approved indications for Nivolumab and Ipilimumab in Combination for Metastatic Cancer?

Nivolumab and Ipilimumab in combination is commonly used to treat patients with metastatic <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> who have already undergone anti-angiogenic therapy. This treatment method can also be effective against other conditions, such as malignant neoplasms, unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, and <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>.

Q: What other similar studies have there been involving Nivolumab and Ipilimumab in combination with Metastatic Cancer?

At the moment, there are 796 ongoing studies related to Nivolumab and Ipilimumab for metastatic <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>. Out of these trials, 86 are in phase 3. Additionally, 43300 medical facilities around the world are researching this topic.

Q: Are there any participants still needed for this research project?

This particular trial is not looking for any more participants, however this information was last updated on October 28th, 2022. There are 3834 other trials that might be seeking patients.

Q: What is the stance of the FDA on Nivolumab and Ipilimumab as a combination treatment for cancer that has spread?

Nivolumab and Ipilimumab's safety for treating metastatic <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> received a score of 2.

Phase 2

Waitlist Available

Research Sponsored by Parker Institute for Cancer Immunotherapy

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 from initiation of study drug until death due to any cause, up to 43 months

Awards & highlights

Study Summary

This trial will study whether a person's response to a cancer immunotherapy drug combo may be predicted by the proportion of a certain type of immune cell in their tumor.

Eligible Conditions

Metastatic Cancer
Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from initiation of study drug until death due to any cause, up to 43 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from initiation of study drug until death due to any cause, up to 43 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of study drug until death due to any cause, up to 43 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Benefit Rate (CBR) of Nivolumab With or Without Ipilimumab

Percentage of Participants Whose Tumors Convert From CD8 Low (<15% Tumoral CD8) to CD8 High (>=15%).

Secondary outcome measures

Number of Participants With Treatment-related Adverse Events (TRAE)

Objective Response Rate (ORR)

Overall Survival (OS)

+1 more

Side effects data

From 2023 Phase 2 trial • 100 Patients • NCT03651271

33%

Nausea

27%

Constipation

27%

Fatigue

27%

Vomiting

27%

Rash

27%

Weight Decreased

20%

Immune-Mediated Enterocolitis

20%

Aspartate Aminotransferase Increased

20%

Alanine Aminotransferase Increased

20%

Hypothyroidism

20%

Cough

20%

Dyspnoea

20%

Back pain

20%

Hypokalaemia

20%

Diarrhoea

13%

Pain In Extremity

13%

Adrenal Insufficiency

13%

Pancreatic Enzymes Increased

13%

Decreased Appetite

13%

Hyperthyroidism

13%

Anaemia

13%

Anxiety

13%

Hypocalcaemia

13%

Hyponatraemia

13%

Dysphagia

13%

Abdominal Pain

13%

Hypophosphataemia

13%

Hyperkalaemia

13%

Malnutrition

13%

Insomnia

Urinary Retention

Weight Increased

Oral Candidiasis

Skin Infection

Nephrolithiasis

Renal Failure

Thyroid Function Test Abnormal

Tri-Iodothyronine Decreased

Dermatitis Bullous

Otitis Externa

Penile Infection

Hypophysitis

Upper-Airway Cough Syndrome

Haemorrhage Intracranial

Hypotension

Blood Bilirubin Increased

Blood Creatinine Increased

Dry Mouth

Asthenia

Flank Pain

Alanine aminotransferase increased

Adrenocortical Insufficiency Acute

Thyroxine Decreased

Tachycardia

Medical Device Site Cellulitis

Polymyalgia Rheumatica

Pneumonia

Retching

Immune-Mediated Hepatitis

Blood Thyroid Stimulating Hormone Increased

Covid-19

Urinary Tract Infection

Thrombocytopenia

Immune-Mediated Adrenal Insufficiency

Covid-19 Pneumonia

Muscular weakness

Pruritus

Dysphonia

Dehydration

Gastrooesophageal Reflux Disease

Pyrexia

Chills

Skin Laceration

Toothache

Musculoskeletal Chest Pain

Bacteraemia

100%

80%

60%

40%

20%

Study treatment Arm

"Cold" Tumors for Advanced Prostate Cancer Cohort B

"Hot" Tumors for Advanced Metastatic Cancer

"Cold" Tumors for Advanced Metastatic Cancer

"Hot" Tumors for Advanced Prostate Cancer

"Cold" Tumors for Advanced Prostate Cancer Cohort A

Trial Design

5Treatment groups

Experimental Treatment

Group I: "Hot" tumors for Advanced Prostate CancerExperimental Treatment1 Intervention

Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.

Group II: "Hot" tumors for Advanced Metastatic CancerExperimental Treatment1 Intervention

Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.

Group III: "Cold" tumors for Advanced Prostate Cancer Cohort BExperimental Treatment1 Intervention

Participants with < 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.

Group IV: "Cold" tumors for Advanced Prostate Cancer Cohort AExperimental Treatment1 Intervention

Participants with < 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.

Group V: "Cold" tumors for Advanced Metastatic CancerExperimental Treatment1 Intervention

Participants with < 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer

2018

Completed Phase 2

~100

Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer

2018

Completed Phase 2

~100

Nivolumab and Ipilimumab and Combination for Metastatic Cancer

2018

Completed Phase 2

~100

Nivolumab Monotherapy

2018

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Parker Institute for Cancer ImmunotherapyLead Sponsor

9 Previous Clinical Trials

340 Total Patients Enrolled

Cancer Research Institute, New York CityOTHER

20 Previous Clinical Trials

1,199 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,639 Previous Clinical Trials

4,128,932 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals are meeting the requirements for this research project?

"Unfortunately, this particular study is not seeking patients at the moment. However, there are other trials that might be of interest. There are currently 3038 studies actively looking for participants with advanced metastatic cancer and 796 trials for Nivolumab and Ipilimumab and Combination for Metastatic Cancer actively recruiting participants."

Answered by AI

What are the approved indications for Nivolumab and Ipilimumab in Combination for Metastatic Cancer?

"Nivolumab and Ipilimumab in combination is commonly used to treat patients with metastatic cancer who have already undergone anti-angiogenic therapy. This treatment method can also be effective against other conditions, such as malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

What other similar studies have there been involving Nivolumab and Ipilimumab in combination with Metastatic Cancer?

"At the moment, there are 796 ongoing studies related to Nivolumab and Ipilimumab for metastatic cancer. Out of these trials, 86 are in phase 3. Additionally, 43300 medical facilities around the world are researching this topic."

Answered by AI

Are there any participants still needed for this research project?

"This particular trial is not looking for any more participants, however this information was last updated on October 28th, 2022. There are 3834 other trials that might be seeking patients."

Answered by AI