NCT03203473

Study of Optimized Management of Nivolumab Based on Response in Patients With Advanced RCC (OMNIVORE Study)

Active, enrolled Phase 2 Results posted Last updated 6 February 2026

What this trial tests

Phase 2 trial testing Ipilimumab in Renal Cancer in 85 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 October 2017

Primary endpoint
30 November 2021

28 June 2026

Quick facts

Lead sponsor	Toni Choueiri, MD
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	85
Start date	26 October 2017
Primary completion	30 November 2021
Estimated completion	28 June 2026
Sites	8 locations across United States

Drugs / interventions tested

• Ipilimumab — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Renal Cancer — all drugs for Renal Cancer →

Sponsor

Toni Choueiri, MD — full company profile →

Who can join

18 and older, any sex, with Renal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Subjects With Persistent Partial Response (PR) or Complete Response (CR) at 1 Year Since Nivolumab Discontinuation (Arm A Only) Primary · From nivolumab discontinuation until 1 year after discontinuation with nivolumab

Persistent PR or CR is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks after patients discontinued nivolumab induction therapy. At 1 year after nivolumab discontinuation, the percentage of patients with persistent PR and CR were reported (for Arm A only).

Group	Value	95% CI
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)	42	18 – 68

Percentage of Subjects With Stable or Progressive Disease (SD/PD) to Nivolumab Induction That Convert to Complete or Partial Response (CR/PR) Upon the Addition of Ipilimumab to Nivolumab (Arm B Only) Primary · For arm B patients, from arm B treatment (nivolumab+ipilimumab) initiation until last imaging assessment during the treatment; assessed up to 22 months.

Response is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guideline. After initiation of ipilimumab, Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks until disease progression. Best overall response during Arm B treatment were summarized with 90% confidence interval.

Group	Value	95% CI
Arm B Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)	4	1 – 11

Median Progression Free Survival (Arm B) Secondary · After initiation of Arm B treatment, patients underwent imaging at 12 weeks and then every 8 weeks, up to 22 months.

Progression-free survival (PFS) for Arm B was defined as time from the start of arm B treatment until progression (by RECIST 1.1 or clinical PD) or death from any cause or censored at date of last disease evaluation for those who are alive and have not progressed. PFS distribution was estimated using the product-limit method of Kaplan-Meier, median and 95% confidence interval was reported.

Group	Value	95% CI
Arm B Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)	4.7	2.7 – 8.3

18-month Overall Survival Rate From Initiation of Nivolumab Induction (Overall Cohort) Secondary · Patients were followed from initiation of Nivolumab induction until to death or date last known alive. Kaplan-Meier curve for OS assessed up to 28 months; the 18-month time point estimate for OS was reported.

Overall survival (OS) was defined as the time from initiation of nivolumab induction until death due to any cause or censored at date of last follow-up for surviving patients. OS rate was estimated using the product-limit method of Kaplan-Meier;18-month OS rate and 95% confidence interval were reported.

Group	Value	95% CI
Initial Primary Treatment With Nivolumab (Induction Phase)	79	67 – 87

Percent of Subjects Who Were Free of Nivolumab Salvage Therapy at 1 Year Since Discontinuation of Nivolumab Induction (Arm A) Secondary · For arm A, from nivolumab discontinuation until 1 year after discontinuation with nivolumab

Number and proportion of arm A patients who remained free of nivolumab treatment at 1 year since discontinuation of nivolumab induction

Group	Value	95% CI
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)	42	18 – 68

Percentage of Subjects Who Experience Grade 3-4 Treatment-related Adverse Event (TRAE) During the Nivolumab Induction Therapy (Overall Cohort) Secondary · Adverse events during the nivolumab induction were measured from nivolumab initiation until 3 months following the last dose of nivolumab induction or until start of arm B treatment, assessed up to 9 months from nivolumab start

Adverse event was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4. The following AE attribution was considered as treatment-related: * Definite - The AE is clearly related to the study treatment. * Probable - The AE is likely related to the study treatment. * Possible - The AE may be related to the study treatment.

Group	Value	95% CI
Initial Primary Treatment With Nivolumab (Induction Phase)	7	3 – 15

Percentage of Subjects Who Experienced Grade 3-4 Treatment Related Adverse Events (TRAE) During the Arm B Treatment (Arm B Only) Secondary · For arm B, adverse events were measured from arm B treatment initiation until 3 months following the last dose of arm B treatment, assessed up to 26 months from arm B start

Adverse event was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4. The following AE attribution was considered as treatment-related: * Definite - The AE is clearly related to the study treatment. * Probable - The AE is likely related to the study treatment. * Possible - The AE may be related to the study treatment.

Group	Value	95% CI
Arm B Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)	25	14 – 38

Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivolumab Induction Therapy According to International mRCC Database Consortium (IMDC) Risk Groups. Secondary · From start of nivolumab induction until the discontinuation of nivolumab induction, assessed up to 7 months

Response (PR or CR) is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks during the induction therapy with nivolumab.

IMDC favorable risk

Group	Value	95% CI
Initial Primary Treatment With Nivolumab (Induction Phase)	11	3 – 26

IMDC intermediate risk

Group	Value	95% CI
Initial Primary Treatment With Nivolumab (Induction Phase)	13	6 – 25

IMDC poor risk

Group	Value	95% CI
Initial Primary Treatment With Nivolumab (Induction Phase)	9	1 – 36

Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivolumab Induction Therapy According to Prior Treatment Secondary · From start of nivolumab induction until the discontinuation of nivolumab induction, assessed up to 7 months

Response (PR or CR) is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks during the induction therapy with nivolumab.

Treatment Naive

Group	Value	95% CI
Initial Primary Treatment With Nivolumab (Induction Phase)	12	5 – 23

Previously treated

Group	Value	95% CI
Initial Primary Treatment With Nivolumab (Induction Phase)	12	5 – 24

Adverse events — posted to ClinicalTrials.gov

Time frame: Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)

Serious: 6/83 (7%)

Deaths: 19/83

Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)

Serious: 14/57 (25%)

Deaths: 12/57

Arm A: Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)

Serious: 0/12 (0%)

Deaths: 1/12

Serious adverse events (25 terms)

Reaction	System	Overall Cohort: Initial Pr…	Arm B: Nivolumab+Ipilimuma…	Arm A: Arm A-Observation A…
Hyperglycemia	Metabolism and nutrition disorders	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—
Colitis	Gastrointestinal disorders	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Acidosis	Metabolism and nutrition disorders	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Blood bilirubin increased	Investigations	—	—	—
CPK increased	Investigations	—	—	—
Creatinine increased	Investigations	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Eye disorders - Other, specify	Eye disorders	—	—	—
General disorders and administration site conditions - Other, specify	General disorders and administration site conditions	—	—	—
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—
Infusion related reaction	General disorders and administration site conditions	—	—	—
Myositis	Musculoskeletal and connective tissue disorders	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—
Portal hypertension	Hepatobiliary disorders	—	—	—
Portal vein thrombosis	Hepatobiliary disorders	—	—	—
Renal and urinary disorders - Other, specify	Renal and urinary disorders	—	—	—

Other adverse events (175 terms — click to expand)

Reaction	System	Overall Cohort: Initial Pr…	Arm B: Nivolumab+Ipilimuma…	Arm A: Arm A-Observation A…
Fatigue	General disorders and administration site conditions	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Pain	General disorders and administration site conditions	—	—	—
Edema limbs	General disorders and administration site conditions	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Creatinine increased	Investigations	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—
Fever	General disorders and administration site conditions	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Rash acneiform	Skin and subcutaneous tissue disorders	—	—	—
Upper respiratory infection	Infections and infestations	—	—	—
Weight gain	Investigations	—	—	—
Weight loss	Investigations	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: Hyperglycemia, Adrenal insufficiency, Colitis, Hyperkalemia, Hyponatremia, Acidosis, Alanine aminotransferase increased, Alkaline phosphatase increased.

Data from ClinicalTrials.gov NCT03203473 adverse events section.

Sponsor's own description

This research study is studying two drugs at different time points as a possible treatment for advanced renal cell cancer

The drugs involved in this study are:

Nivolumab Ipilimumab

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Research Status and Outlook of PD-1/PD-L1 Inhibitors for Cancer Therapy.
   Ai L, Chen J, Yan H, He Q, et al · · 2020 · cited 149× · PMID 32982171 · DOI 10.2147/dddt.s267433
2. Optimized Management of Nivolumab and Ipilimumab in Advanced Renal Cell Carcinoma: A Response-Based Phase II Study (OMNIVORE).
   McKay RR, McGregor BA, Xie W, Braun DA, et al · · 2020 · cited 82× · PMID 33108238 · DOI 10.1200/jco.20.02295
3. Salvage Ipilimumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma After Prior Immune Checkpoint Inhibitors.
   Gul A, Stewart TF, Mantia CM, Shah NJ, et al · · 2020 · cited 76× · PMID 32491962 · DOI 10.1200/jco.19.03315
4. Treatment-Free Survival: A Novel Outcome Measure of the Effects of Immune Checkpoint Inhibition-A Pooled Analysis of Patients With Advanced Melanoma.
   Regan MM, Werner L, Rao S, Gupte-Singh K, et al · · 2019 · cited 65× · PMID 31498030 · DOI 10.1200/jco.19.00345
5. Ipilimumab in combination with nivolumab for the treatment of renal cell carcinoma.
   Gao X, McDermott DF. · · 2018 · cited 47× · PMID 30124333 · DOI 10.1080/14712598.2018.1513485
6. Ipilimumab and Nivolumab as First-Line Treatment of Patients with Renal Cell Carcinoma: The Evidence to Date.
   Sheng IY, Ornstein MC. · · 2020 · cited 35× · PMID 32606975 · DOI 10.2147/cmar.s202017
7. Longitudinal Molecular Profiling of Circulating Tumor Cells in Metastatic Renal Cell Carcinoma.
   Bootsma M, McKay RR, Emamekhoo H, Bade RM, et al · · 2022 · cited 24× · PMID 35617646 · DOI 10.1200/jco.22.00219
8. From Bench to Bedside: How the Tumor Microenvironment Is Impacting the Future of Immunotherapy for Renal Cell Carcinoma.
   Anker J, Miller J, Taylor N, Kyprianou N, et al · · 2021 · cited 19× · PMID 34831452 · DOI 10.3390/cells10113231