Reported positive (1)
- Targeting PD-L1 for non-small-cell lung cancer
Review · Moderate evidence · Jun 2016
Nivolumab †Rx
Rx ICI: PD-1 ↓ → T-cell ↑; OS/PFS across melanoma/NSCLC/RCC/HNSCC/MSI-high; irAE management key.
Evidence at a glanceHuman trial / meta-analysisMixed results⚠ Studies disagree
3 published studies tagged to this agent1 human studies approved & graded (trial, observational, or meta-analysis)
Why this grade?
Human trial / meta-analysis — Includes human trial or meta-analysis evidence.
- 1 human · 0 animal · 0 lab · 2 review/other
- Most authoritative study: ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer
- Studies disagree on the reported direction (conflict flagged).
- Findings conflict across studies
- No numeric effect sizes reported
Computed deterministically from the studies’ types and reported outcomes — not written by AI, and not a claim that anything works.
🏥⭐⭐⭐⭐⭐ Strong — FDA-approved across many cancers with consistent OS/PFS benefits in phase III trials.OpdivoBMS-936558MDX-1106
Forms: IV infusion (10 mg/mL concentrate) · Prefilled syringes (100 mg/10 mL, 240 mg/24 mL)
Educational only, not medical advice. OncoForge makes no claim that Nivolumab †Rx treats, prevents, or cures any condition, beyond what the linked studies show. Evidence levels vary; effects may not translate to people, and some compounds can cause harm. Always coordinate with your oncology team.
Key Takeaway
Anti–PD-1 checkpoint inhibitor that restores exhausted T cells and delivers survival gains across multiple cancers (melanoma, NSCLC, RCC, HNSCC, others); requires vigilant monitoring for immune-related toxicities.
Evidence at a glance
Tier 5MelanomaNSCLCRCCHNSCC
20+ phase III approvals; OS HR 0.6-0.8 in frontline; durable 5y OS 30-50% in melanoma/NSCLC; meta-combination benefits with CTLA-4i/chemo; ongoing in adjuvant/metastatic.
How it may work
By binding PD-1 on T cells, nivolumab prevents engagement with PD-L1/PD-L2, reversing T-cell exhaustion and boosting cytotoxic activity and memory responses. Tumor control stems from renewed CD8⁺ infiltration and effector function. Durable response ‘tails’ on survival curves occur in subsets with immunogenic tumors or high neoantigen burden.
Targets & pathways
Curated mechanistic targets reported for this agent — how it may act on cells, not proof of a clinical effect.
Often studied / combined with
Combinations reported in the literature, not a protocol or a recommendation.
- Ipilimumab: CheckMate 067: 5y OS 52% in melanoma combo.
- Chemotherapy: CheckMate 9LA: OS HR 0.72 in NSCLC frontline.
- Curcumin: Preclinical irAE mitigation and T-cell boost.
- Resveratrol: Enhanced effector function in lung models.
Overlapping mechanisms
- PD-1: Cross-resistance with pembro/cemi; switch to CTLA-4 or LAG-3.
- T-Cell Activation: Redundant in hot tumors; consider tumor microenvironment priming.
Safety & interactions
Severity and how well-established each signal is are shown separately. Verify everything with your oncologist or pharmacist — absence here does not mean safe.
Risk categories
IrAEFatigueInfusion Reaction
Potential interactions
- corticosteroidsUse For IrAELowTheoreticalHigh-dose for toxicity; low-dose physiologic OK.
- immunosuppressantsAvoidHighTheoreticalBlunts efficacy (e.g., chronic steroids).
- IpilimumabSynergizeModerateTheoreticalHigher irAE but OS gains in melanoma.
Timing
- Outpatient: 30-min IV; monitor 1h post for reactions.
- q2-4w: Cycle-dependent; continuous until progression/tox.
References
- NBK567801: Nivolumab mechanism and approvals
- PMC11899125: T-cell reinvigoration biomarkers
- DOI 10.1186/s12943-024-02212-7: PD-1 blockade review
- DOI 10.1016/j.intimp.2024.113547: irAE management
- NEJM 2015: CheckMate 066 NSCLC trial
- PMC10221542: Natural compound synergies with ICIs
Research
Where the evidence is
What has been studied, and how strong it is, by topic. A dashed cell means no studies were found for that combination — a gap, not evidence of no effect. Open a row to see its studies.
CancerHuman evidenceMechanismSafetyTrial
Fallopian Tube Cancer11—1
High Grade Epithelial Ovarian Cancer11—1
Ovarian Cancer11—1
Primary Peritoneal Cancer11—1
Non Small Cell Lung Cancer—1——
- Targeting PD-L1 for non-small-cell lung cancer ReviewReported positive
Uterine Leiomyosarcoma————
Study mix
3 published studies by what they were done in. Lab and animal findings often do not carry over to people.
1 Human2 Review/other
Reported directionReported positive1Mixed results1Inconclusive1
What supports this page
The kinds of sources behind this page, strongest at the top. Faint rungs show what is not here yet.
Guideline0
Meta-analysis0
Systematic review0
Randomized trial0
Clinical trial1
Observational0
Case report0
Review2
Preclinical0
Other0
3 studies1 human2 review/other
Tracking 3 published studies of Nivolumab †Rx: 1 in humans, 2 reviews/other.
Reported direction across studies: 1 positive, 1 mixed, 1 inconclusive.
Findings conflict — both supportive and negative/mixed results exist (see below). Human evidence is limited.
These counts summarize what the studies reported; they are not a measure of whether Nivolumab †Rx works.
Cancers named in these studies
Conflicting evidence
Negative or mixed (1)
- Uterine leiomyosarcoma: A review of the literature and update on management options
Review · Limited evidence · Dec 2018
All studies
Human trialTrialInconclusiveLimited evidenceTier 4 · clinicaln = 1000
ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · Dec 2021 · Randomized, double-blind, phase III, international, multicenter; two independent comparisons (ATHENA-MONO and ATHENA-COMBO) with 4:4:1:1 randomization
RucaparibNivolumabovarian cancerfallopian tube cancerprimary peritoneal cancerhigh-grade epithelial ovarian cancer
This report describes ATHENA, a randomized, double-blind phase III trial testing rucaparib as frontline maintenance versus placebo (ATHENA-MONO) and rucaparib plus nivolumab versus rucaparib alone (ATHENA-COMBO) in women with newly diagnosed ovarian, fallopian tube, or peritoneal cancer who responded to platinum-based chemotherapy. About 1000 patients were randomized into four arms (rucaparib+nivolumab; rucaparib+placebo; placebo+nivolumab; placebo+placebo); the primary endpoint is investigator-assessed progression-free survival. The trial completed accrual in 2020 and primary results for ATHENA-MONO were anticipated in early 2022; no outcome data are reported in this abstract.
Studied with: nivolumab.
Key findings
- Primary objectives: assess rucaparib monotherapy versus placebo (ATHENA-MONO) and rucaparib+nivolumab versus rucaparib alone (ATHENA-COMBO) as frontline maintenance after response to platinum-based chemotherapy.
- Design: international, randomized, double-blind phase III trial with two independent comparisons sharing a common arm; patients randomized 4:4:1:1 to arms A–D.
- Dosing: rucaparib starting dose 600 mg orally twice daily; nivolumab 480 mg IV every 4 weeks.
- Primary endpoint: investigator-assessed progression-free survival per RECIST v1.1.
- Sample size and status: approximately 1000 patients enrolled and randomized; accrual completed in 2020; ATHENA-MONO primary results anticipated in early 2022, ATHENA-COMBO to mature later.
Limitations: Abstract reports trial design and enrollment only; no efficacy or safety results are provided.; Primary endpoint is investigator-assessed PFS (no mention of blinded central review in abstract).; Population limited to patients who achieved response to initial cytoreductive surgery and platinum-based chemotherapy; results may not generalize to all ovarian cancer patients.; Although comparisons are independently powered, ATHENA-MONO and ATHENA-COMBO share a common treatment arm, which may have analytic implications (not detailed in abstract)..
AI summary of the abstract, human-reviewed · Jul 2026. Describes what this study reported, not medical advice. View on PubMed · Full text
ReviewMixed resultsLimited evidenceTier 4 · clinical
Uterine leiomyosarcoma: A review of the literature and update on management options
Gynecologic oncology · Dec 2018 · literature review
This is a literature review of uterine leiomyosarcoma covering epidemiology, presentation, diagnosis, pathology, and management. The authors state that early-stage management is surgical (hysterectomy) and that routine oophorectomy or lymph node dissection appear to provide little benefit; adjuvant therapy remains controversial with trials failing to show overall survival benefit. They note recent progress in advanced/recurrent disease with novel chemotherapeutics, targeted agents (olaratumab, pazopanib) and immune checkpoint inhibitors (nivolumab, pembrolizumab) showing promise.
Key findings
- Uterine leiomyosarcoma is an aggressive malignancy with poor overall prognosis.
- Preoperative diagnosis is difficult and often only made at time of surgical resection.
- Early stage management entails hysterectomy and complete resection of gross tumor; routine oophorectomy or lymph node dissection do not appear to confer much clinical benefit.
- Adjuvant therapy for early stage disease is controversial; multiple clinical trials have failed to demonstrate benefit on overall survival.
- Recent progress has been made for advanced and recurrent disease with novel chemotherapeutics, targeted therapies such as olaratumab and pazopanib, and immunotherapies such as nivolumab and pembrolizumab demonstrating promise.
Limitations: This article is a narrative literature review and does not present new primary patient data.; No systematic review or meta-analysis methods are described in the abstract.; Uterine leiomyosarcoma is a rare disease, limiting the size and power of available trials summarized.; Adjuvant therapy efficacy is uncertain because multiple trials failed to show overall survival benefit..
AI summary of the abstract, human-reviewed · Jul 2026. Describes what this study reported, not medical advice. View on PubMed
ReviewReported positiveModerate evidenceTier 4 · clinical
Targeting PD-L1 for non-small-cell lung cancer
Immunotherapy · Jun 2016
This is a review of PD-1 and PD-L1 immune checkpoint inhibitors in non-small-cell lung cancer (NSCLC). The abstract states that anti-PD-1 antibodies nivolumab and pembrolizumab are FDA-approved for NSCLC and other tumor types, and that additional agents targeting this pathway are in clinical development. The review summarizes updates on these agents being evaluated in NSCLC patients.
Key findings
- Immune checkpoint inhibitors act by inhibiting negative T-cell regulators and exert antitumor effects.
- The anti-PD-1 antibodies nivolumab and pembrolizumab are approved by the US FDA for treatment of patients with NSCLC and other tumor types.
- Additional PD-1/PD-L1 agents are in clinical development for NSCLC.
- The article provides an update on PD-1 and PD-L1 immune checkpoint inhibitors currently being evaluated in NSCLC patients.
Limitations: Review article — does not present original patient-level data or new primary results.; Abstract provides no quantitative efficacy or safety outcomes, trial details, or comparative results.; No specific clinical trial data, dosing, or follow-up durations are reported in the abstract..
AI summary of the abstract, human-reviewed · Jul 2026. Describes what this study reported, not medical advice. View on PubMed
What changed recently
The latest additions to Nivolumab †Rx's evidence base, and anything that's been retracted.
Recently added- Targeting PD-L1 for non-small-cell lung cancer Review · added Jul 2026
- Uterine leiomyosarcoma: A review of the literature and update on management options Review · added Jul 2026
- ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer Human trial · added Jul 2026
Cancers where Nivolumab †Rx reported positive results
Where at least one study reported a positive result, shown with the full picture, not just the wins. Positive results are more likely to be published, and most of these are early lab or animal studies that may not translate to people. This reports what studies found, not what works.
Preclinical only: lab / animal (1)
Non-small-cell lung cancer1 positive
Limitations: Review article — does not present original patient-level data or new primary results.; Abstract provides no quantitative efficacy or safety outcomes, trial details, or comparative results.; No specific clinical trial data, dosing, or follow-up durations are reported in the abstract..
Cited positive studies (1)
- Targeting PD-L1 for non-small-cell lung cancer Review · Jun 2016
Evidence at a glance: Nivolumab †Rx by cancer
A deterministic grade of what published studies report for each: strength of evidence, the reported direction, and the largest credible effect, strongest-evidence first. This summarizes findings; it is not a claim that anything works.
Includes human trial or meta-analysis evidence.
No numeric effect sizes reported · Based on a single study.
Includes human trial or meta-analysis evidence.
No numeric effect sizes reported · Based on a single study.
Includes human trial or meta-analysis evidence.
No numeric effect sizes reported · Based on a single study.
Primary peritoneal cancerHuman trial / meta-analysisInconclusive1 human
Includes human trial or meta-analysis evidence.
No numeric effect sizes reported · Based on a single study.
No primary experimental studies yet.
Most authoritative study: Targeting PD-L1 for non-small-cell lung cancer
No human studies yet · No numeric effect sizes reported · Based on a single study.
No primary experimental studies yet.
Most authoritative study: Uterine leiomyosarcoma: A review of the literature and update on management options
No human studies yet · No numeric effect sizes reported · Based on a single study.
Dose: as studied, not a recommendation
These are doses as studied or reported, never a recommendation. The right amount of Nivolumab †Rx depends on you, your other medicines, and your situation; decide it with your oncology team and pharmacist, not from a web page.
Ranges seen in adjunct / practice use: 240–480 mg IV q2-4w (IV) Flat dose: 240 mg q2w or 480 mg q4w; weight-based alternatives, Most tumors 240 mg q2w; melanoma/RCC 480 mg q4w; infuse over 30 min; premed not required..
Doses reported in studies- ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer Rucaparib 600 mg orally twice daily; nivolumab 480 mg intravenously every 4 weeks (starting doses) · Human trial · Dec 2021
Clinical trials studying Nivolumab †Rx
32 ongoing · 18 completed · tracked from ClinicalTrials.gov. Recruiting is not the same as proven, and completed is not the same as positive — read the results. Not a recommendation.
Completed
- TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers
- IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors
- Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic MalignanciesPrimary outcome measured: Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
- An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors
- A Study of a Personalized Neoantigen Cancer Vaccine
- Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for ChemoPrimary outcome measured: Progression-free Survival (PFS)
- Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine LeiomyosarcomaPrimary outcome measured: Objective Response Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Among Patients With Advanced Leiomyosarcoma of the Uterus (ULMS) Treated With Nivolumab (Cohort A)
- A Phase I Study of WT1 or NY-ESO-1 Vaccine and Nivolumab For Recurrent Ovarian Cancer
- A Study of MDX-1106 in Patients With Selected Refractory or Relapsed MalignanciesPrimary outcome measured: Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population
- Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone SarcomasNCT03277924Phase 1 / Phase 2Completed Sun Jun 30tests Methotrexatetests Nivolumabtests Cisplatintests Dacarbazinetests Ifosfamidetests Doxorubicin
- Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube CancerPrimary outcome measured: Objective Tumor Response
- A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid TumorsNCT02009449Phase 1Completed Sat Jul 22tests Carboplatintests Nivolumabtests Paclitaxeltests Pembrolizumabtests Cisplatintests Gemcitabine
- Preoperative Nivolumab in Patients With Locally Advanced Colon Cancer (T3 or T4): a Window-of-opportunity Study
- Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis
- Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLCPrimary outcome measured: Number of Participants With Dose Limiting Toxicity (DLT)
- A Study of Nivolumab in Selected Uterine Cancer PatientsPrimary outcome measured: Progression-Free Survival
- A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid TumorsPrimary outcome measured: Overall Response Rate (ORR)
10 stopped (terminated / withdrawn / suspended)
- Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative · Suspended
- Anti-CTLA4-NF mAb (BMS986218), Nivolumab, and Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Malignancies · Terminated
- Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies · Terminated
- An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease · Withdrawn
- Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer · Terminated
- FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors · Terminated
- Cabozantinib Plus Nivolumab and Ipilimumab in Women With Recurrent Gynecologic Carcinosarcoma · Withdrawn
- A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES) · Terminated
- Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma · Terminated
- Vigil™ + Nivolumab in Advanced Non-Small Cell Lung Cancer · Withdrawn
Inclusion here is not an endorsement. OncoForge makes no claim beyond what the linked studies show. Discuss anything on this page with your oncology team before acting on it.